3rd NATIONAL CONGRESS REPORT ON ACTIVITIES
- TRANSPORT and OMNBUS WORKERS UNION (TOWU)
- Authors: TRANSPORT and OMNBUS WORKERS UNION (TOWU)
- Date: 2006
- Subjects: TOWU
- Language: English
- Type: text
- Identifier: http://hdl.handle.net/10962/178927 , vital:43021
- Full Text:
- Date Issued: 2006
- Authors: TRANSPORT and OMNBUS WORKERS UNION (TOWU)
- Date: 2006
- Subjects: TOWU
- Language: English
- Type: text
- Identifier: http://hdl.handle.net/10962/178927 , vital:43021
- Full Text:
- Date Issued: 2006
A critical review of participatory practice in integrated water resource management
- Lotz-Sisitka, Heila, Burt, Jane C
- Authors: Lotz-Sisitka, Heila , Burt, Jane C
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , report
- Identifier: http://hdl.handle.net/10962/437450 , vital:73380 , ISBN 1-77005-388-3 , https://wrcwebsite.azurewebsites.net/wp-content/uploads/mdocs/Project_1434_01_06.pdf
- Description: As indicated in Chapter 1, the expected outputs of this research are guidelines for best practice, and a set of indicators for monitoring and evaluation of participatory practice in CMA establishment. Chapter 1 indicated that participatory practice in CMA establishment in South Afri-ca is located in a particular social context: that of institution building in a democratising society (where the models of democracy may not be clearly articulated or well understood amongst South African citizens), in response to new national legislation that is based on principles of equi-ty, efficiency and sustainability. This context is further shaped by a his-tory of inequality and lack of broad participation in IWRM. Chapter 1 al-so indicated that IWRM in South Africa crosses political boundaries, is framed within geo-physical boundaries, and is complicated by different governance frameworks for water service delivery and water resources management (where water services delivery is a key priority for people on the ground who have traditionally not had access to water). Water resources management is therefore likely to be a ‘secondary’priority, and the possibility exists that the two needs could be confused amongst those who are to participate in IWRM in South Africa.
- Full Text:
- Date Issued: 2006
- Authors: Lotz-Sisitka, Heila , Burt, Jane C
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , report
- Identifier: http://hdl.handle.net/10962/437450 , vital:73380 , ISBN 1-77005-388-3 , https://wrcwebsite.azurewebsites.net/wp-content/uploads/mdocs/Project_1434_01_06.pdf
- Description: As indicated in Chapter 1, the expected outputs of this research are guidelines for best practice, and a set of indicators for monitoring and evaluation of participatory practice in CMA establishment. Chapter 1 indicated that participatory practice in CMA establishment in South Afri-ca is located in a particular social context: that of institution building in a democratising society (where the models of democracy may not be clearly articulated or well understood amongst South African citizens), in response to new national legislation that is based on principles of equi-ty, efficiency and sustainability. This context is further shaped by a his-tory of inequality and lack of broad participation in IWRM. Chapter 1 al-so indicated that IWRM in South Africa crosses political boundaries, is framed within geo-physical boundaries, and is complicated by different governance frameworks for water service delivery and water resources management (where water services delivery is a key priority for people on the ground who have traditionally not had access to water). Water resources management is therefore likely to be a ‘secondary’priority, and the possibility exists that the two needs could be confused amongst those who are to participate in IWRM in South Africa.
- Full Text:
- Date Issued: 2006
A Discussion Of Wireless Security Technologies
- Janse van Rensburg, Johanna, Irwin, Barry V W
- Authors: Janse van Rensburg, Johanna , Irwin, Barry V W
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/429852 , vital:72645 , https://www.researchgate.net/profile/Barry-Ir-win/publication/228864029_A_DISCUSSION_OF_WIRELESS_SECURITY_TECHNOLOGIES/links/53e9c5190cf28f342f41492b/A-DISCUSSION-OF-WIRELESS-SECURITY-TECHNOLOGIES.pdf
- Description: The 802.11 standard contains a number of problems, ranging from in-terference, co-existence issues, exposed terminal problems and regula-tions to security. Despite all of these it has become a widely deployed technology as an extension of companies’ networks to provide mobility. In this paper the focus will be on the security issues of 802.11. Several solutions for the deployment of 802.11 security exists today, ranging from WEP, WPA, VPN and 802.11 i, each providing a different level of security. These technologies contain pros and cons which need to be understood in order to implement an appropriate solution suited to a specific scenario.
- Full Text:
- Date Issued: 2006
- Authors: Janse van Rensburg, Johanna , Irwin, Barry V W
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/429852 , vital:72645 , https://www.researchgate.net/profile/Barry-Ir-win/publication/228864029_A_DISCUSSION_OF_WIRELESS_SECURITY_TECHNOLOGIES/links/53e9c5190cf28f342f41492b/A-DISCUSSION-OF-WIRELESS-SECURITY-TECHNOLOGIES.pdf
- Description: The 802.11 standard contains a number of problems, ranging from in-terference, co-existence issues, exposed terminal problems and regula-tions to security. Despite all of these it has become a widely deployed technology as an extension of companies’ networks to provide mobility. In this paper the focus will be on the security issues of 802.11. Several solutions for the deployment of 802.11 security exists today, ranging from WEP, WPA, VPN and 802.11 i, each providing a different level of security. These technologies contain pros and cons which need to be understood in order to implement an appropriate solution suited to a specific scenario.
- Full Text:
- Date Issued: 2006
A generic database and spatial interface for the application of hydrological and water resource models
- Hughes, Denis A, Forsyth, D A
- Authors: Hughes, Denis A , Forsyth, D A
- Date: 2006
- Language: English
- Type: text , Article
- Identifier: vital:7080 , http://hdl.handle.net/10962/d1012333
- Description: The paper discusses a software package that has been designed to enhance the efficiency of applying a range of hydrological and water resource simulation models. The SPATSIM (SPatial and Time Series Information Modeling) system has been developed in Delphi using MapObjects and incorporates a spatial data interface for access to the different types of information commonly associated with water resource analyses. All of the information is stored within database tables (Paradox by default) with generic structures. The structure and components of the system are briefly described and some example applications provided. The discussion identifies some of the criticisms that have been leveled at the software, the approach of the developers to user support and some possible future developments. The conclusions suggest that the development can be considered successful in that it has substantially improved the efficiency of the Institute for Water Research to undertake one of its core functions of hydrological model development and application.
- Full Text:
- Date Issued: 2006
- Authors: Hughes, Denis A , Forsyth, D A
- Date: 2006
- Language: English
- Type: text , Article
- Identifier: vital:7080 , http://hdl.handle.net/10962/d1012333
- Description: The paper discusses a software package that has been designed to enhance the efficiency of applying a range of hydrological and water resource simulation models. The SPATSIM (SPatial and Time Series Information Modeling) system has been developed in Delphi using MapObjects and incorporates a spatial data interface for access to the different types of information commonly associated with water resource analyses. All of the information is stored within database tables (Paradox by default) with generic structures. The structure and components of the system are briefly described and some example applications provided. The discussion identifies some of the criticisms that have been leveled at the software, the approach of the developers to user support and some possible future developments. The conclusions suggest that the development can be considered successful in that it has substantially improved the efficiency of the Institute for Water Research to undertake one of its core functions of hydrological model development and application.
- Full Text:
- Date Issued: 2006
A history of southern African research relevant to forensic entomology
- Williams, Kirstin A, Villet, Martin H
- Authors: Williams, Kirstin A , Villet, Martin H
- Date: 2006
- Language: English
- Type: text , Article
- Identifier: vital:6909 , http://hdl.handle.net/10962/d1011862
- Description: Entomological forensic evidence has been used in southern Africa for decades but explicitly forensic research began in southern Africa only 26 years ago. Although applicable local research has accumulated since 1921, it is scattered in a diverse literature or unpublished. Some overseas research has also touched on local species. This review uses a historical approach to synthesize the southern African literature and to illustrate the cross-disciplinary, opportunistic nature of forensic entomology. Distinct phases of research focused on agriculture (1921-1950), medicine (1952- 1965), ecology (1968-1990) and forensics (1980-2005), but systematics spanned the entire period and tended to be ad hoc. Few scientists were involved, situated at geographically distant locations and with widely disparate research interests. The review concludes with an overview of southern African entomologists who have been involved in medico-legal investigations, and a critical evaluation of the past and future of the discipline locally.
- Full Text:
- Date Issued: 2006
- Authors: Williams, Kirstin A , Villet, Martin H
- Date: 2006
- Language: English
- Type: text , Article
- Identifier: vital:6909 , http://hdl.handle.net/10962/d1011862
- Description: Entomological forensic evidence has been used in southern Africa for decades but explicitly forensic research began in southern Africa only 26 years ago. Although applicable local research has accumulated since 1921, it is scattered in a diverse literature or unpublished. Some overseas research has also touched on local species. This review uses a historical approach to synthesize the southern African literature and to illustrate the cross-disciplinary, opportunistic nature of forensic entomology. Distinct phases of research focused on agriculture (1921-1950), medicine (1952- 1965), ecology (1968-1990) and forensics (1980-2005), but systematics spanned the entire period and tended to be ad hoc. Few scientists were involved, situated at geographically distant locations and with widely disparate research interests. The review concludes with an overview of southern African entomologists who have been involved in medico-legal investigations, and a critical evaluation of the past and future of the discipline locally.
- Full Text:
- Date Issued: 2006
A new and earlier record of Chrysomya megacephala in South Africa, with notes on another exotic species, Calliphora vicina (Diptera Calliphoridae)
- Williams, Kirstin A, Villet, Martin H
- Authors: Williams, Kirstin A , Villet, Martin H
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/440710 , vital:73805 , https://hdl.handle.net/10520/EJC84554
- Description: South African records of Chrysomya megacephala and Calliphora vicina are reviewed and plotted on maps. Dispersal routes of these two forensically and medically important blowfly species are discussed. Emphasised is the importance of deposition of voucher material in museum collections.
- Full Text:
- Date Issued: 2006
- Authors: Williams, Kirstin A , Villet, Martin H
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/440710 , vital:73805 , https://hdl.handle.net/10520/EJC84554
- Description: South African records of Chrysomya megacephala and Calliphora vicina are reviewed and plotted on maps. Dispersal routes of these two forensically and medically important blowfly species are discussed. Emphasised is the importance of deposition of voucher material in museum collections.
- Full Text:
- Date Issued: 2006
A research prospectus for the humanities
- Authors: Wright, Laurence
- Date: 2006
- Language: English
- Type: Book chapter , text
- Identifier: vital:7027 , http://hdl.handle.net/10962/d1007213
- Description: The humanities in South Africa, as elsewhere, face a crisis of credibility.There is pressing need for the humanities to articulate their social and educational purpose more clearly, so that their academic value is recognised beyond the confines of academia.The aim of reshaping human character and society remains the foundational impulse of the humanities. This is achieved through the careful study of specially selected exemplary 'texts': literary works, fine art, social schemes, intellectual movements, historical episodes, and philosophical and religious outlooks.Students are required to respond in person to both 'text' and the discourse of which it is an exemplary instantiation. This is the manner in which they act to influence character and society.
- Full Text:
- Date Issued: 2006
- Authors: Wright, Laurence
- Date: 2006
- Language: English
- Type: Book chapter , text
- Identifier: vital:7027 , http://hdl.handle.net/10962/d1007213
- Description: The humanities in South Africa, as elsewhere, face a crisis of credibility.There is pressing need for the humanities to articulate their social and educational purpose more clearly, so that their academic value is recognised beyond the confines of academia.The aim of reshaping human character and society remains the foundational impulse of the humanities. This is achieved through the careful study of specially selected exemplary 'texts': literary works, fine art, social schemes, intellectual movements, historical episodes, and philosophical and religious outlooks.Students are required to respond in person to both 'text' and the discourse of which it is an exemplary instantiation. This is the manner in which they act to influence character and society.
- Full Text:
- Date Issued: 2006
A stability-indicating high performance liquid chromatographic assay for the determination of orlistat in capsules
- Mohammadi, Ali, Haririan, I, Rezanour, I, Ghiasi, L, Walker, Roderick B
- Authors: Mohammadi, Ali , Haririan, I , Rezanour, I , Ghiasi, L , Walker, Roderick B
- Date: 2006
- Language: English
- Type: Article , text
- Identifier: vital:6407 , http://hdl.handle.net/10962/d1006480
- Description: A stability-indicating HPLC method was developed and validated for the quantitative determination of orlistat in capsule dosage forms. An isocratic separation was achieved using a Perfectsil® target ODS-3, 250 mm × 4.6 mm i.d., 5 µm particle size column with a flow rate of 0.7 ml/min and using a UV detector to monitor the eluate at 210 nm. The mobile phase consisted of methanol:acetonitrile:trifluoroacetic acid (82.5:17.5:0.01, v/v/v). The drug was subjected oxidation, hydrolysis, photolysis and heat to apply stress conditions. Complete separation was achieved for the parent compound and all degradation products in an overall analytical run time of approximately 15 min with the parent compound orlistat eluting at approximately 9 min. The method was linear over the concentration range of 0.02–0.75 mg/ml (r = 0.9998) with a limit of detection and quantitation 0.006 and 0.02 mg/ml, respectively. The method has the requisite accuracy, selectivity, sensitivity and precision to assay orlistat in capsules. Degradation products resulting from the stress studies did not interfere with the detection of orlistat and the assay is thus stability-indicating.
- Full Text:
- Date Issued: 2006
- Authors: Mohammadi, Ali , Haririan, I , Rezanour, I , Ghiasi, L , Walker, Roderick B
- Date: 2006
- Language: English
- Type: Article , text
- Identifier: vital:6407 , http://hdl.handle.net/10962/d1006480
- Description: A stability-indicating HPLC method was developed and validated for the quantitative determination of orlistat in capsule dosage forms. An isocratic separation was achieved using a Perfectsil® target ODS-3, 250 mm × 4.6 mm i.d., 5 µm particle size column with a flow rate of 0.7 ml/min and using a UV detector to monitor the eluate at 210 nm. The mobile phase consisted of methanol:acetonitrile:trifluoroacetic acid (82.5:17.5:0.01, v/v/v). The drug was subjected oxidation, hydrolysis, photolysis and heat to apply stress conditions. Complete separation was achieved for the parent compound and all degradation products in an overall analytical run time of approximately 15 min with the parent compound orlistat eluting at approximately 9 min. The method was linear over the concentration range of 0.02–0.75 mg/ml (r = 0.9998) with a limit of detection and quantitation 0.006 and 0.02 mg/ml, respectively. The method has the requisite accuracy, selectivity, sensitivity and precision to assay orlistat in capsules. Degradation products resulting from the stress studies did not interfere with the detection of orlistat and the assay is thus stability-indicating.
- Full Text:
- Date Issued: 2006
A stability-indicating high performance liquid chromatographic assay for the determination of orlistat in capsules
- Mohammadi, Ali, Haririan, I, Rezanour, Nasrin, Ghiasi, L, Walker, Roderick B
- Authors: Mohammadi, Ali , Haririan, I , Rezanour, Nasrin , Ghiasi, L , Walker, Roderick B
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/184267 , vital:44195 , xlink:href="https://doi.org/10.1016/j.chroma.2006.03.038"
- Description: A stability-indicating HPLC method was developed and validated for the quantitative determination of orlistat in capsule dosage forms. An isocratic separation was achieved using a Perfectsil® target ODS-3, 250 mm × 4.6 mm i.d., 5 μm particle size column with a flow rate of 0.7 ml/min and using a UV detector to monitor the eluate at 210 nm. The mobile phase consisted of methanol:acetonitrile:trifluoroacetic acid (82.5:17.5:0.01, v/v/v). The drug was subjected oxidation, hydrolysis, photolysis and heat to apply stress conditions. Complete separation was achieved for the parent compound and all degradation products in an overall analytical run time of approximately 15 min with the parent compound orlistat eluting at approximately 9 min. The method was linear over the concentration range of 0.02–0.75 mg/ml (r = 0.9998) with a limit of detection and quantitation 0.006 and 0.02 mg/ml, respectively. The method has the requisite accuracy, selectivity, sensitivity and precision to assay orlistat in capsules. Degradation products resulting from the stress studies did not interfere with the detection of orlistat and the assay is thus stability-indicating.
- Full Text:
- Date Issued: 2006
- Authors: Mohammadi, Ali , Haririan, I , Rezanour, Nasrin , Ghiasi, L , Walker, Roderick B
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/184267 , vital:44195 , xlink:href="https://doi.org/10.1016/j.chroma.2006.03.038"
- Description: A stability-indicating HPLC method was developed and validated for the quantitative determination of orlistat in capsule dosage forms. An isocratic separation was achieved using a Perfectsil® target ODS-3, 250 mm × 4.6 mm i.d., 5 μm particle size column with a flow rate of 0.7 ml/min and using a UV detector to monitor the eluate at 210 nm. The mobile phase consisted of methanol:acetonitrile:trifluoroacetic acid (82.5:17.5:0.01, v/v/v). The drug was subjected oxidation, hydrolysis, photolysis and heat to apply stress conditions. Complete separation was achieved for the parent compound and all degradation products in an overall analytical run time of approximately 15 min with the parent compound orlistat eluting at approximately 9 min. The method was linear over the concentration range of 0.02–0.75 mg/ml (r = 0.9998) with a limit of detection and quantitation 0.006 and 0.02 mg/ml, respectively. The method has the requisite accuracy, selectivity, sensitivity and precision to assay orlistat in capsules. Degradation products resulting from the stress studies did not interfere with the detection of orlistat and the assay is thus stability-indicating.
- Full Text:
- Date Issued: 2006
Accuracy of the activation energy calculated from a thermoluminescence glow‐peak using a method that uses three points on the peak
- Ogundare, F O, Chithambo, Makaiko L
- Authors: Ogundare, F O , Chithambo, Makaiko L
- Date: 2006
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/123016 , vital:35397 , https://doi:10.1002/pssc.200521077
- Description: The utility of thermoluminescence (TL) in detecting changes in defect concentration in insulators is well established [1–3]. The underlying premise leading to the emission of TL is that exposure of a material to ionizing radiation causes a redistribution of charge in defect centres within the material. When the material is heated at a controlled linear rate, the thermoluminescence is emitted as a temperature-dependent set of peaks collectively known as a glow-curve. The shape and intensity of each of the glow-peaks may be characterized by a set of parameters consisting of the activation energy E, the frequency factors, the number of electrons n0 trapped in defect centres at the start of the heating, and the order of kinetics b. The order of kinetics b is an indication of the retrapping probability i.e. the probability that a free electron from the conduction band will be retrapped rather than recombine with a hole at a recombination centre to produce thermoluminescence. Retrapping of electrons reduces the TL intensity at any particular temperature during the heating process. The physical mechanisms of TL associated with a given glow curve are unique and may be characterized by analysis of the glow-curve for the said kinetic parameters.
- Full Text:
- Date Issued: 2006
- Authors: Ogundare, F O , Chithambo, Makaiko L
- Date: 2006
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/123016 , vital:35397 , https://doi:10.1002/pssc.200521077
- Description: The utility of thermoluminescence (TL) in detecting changes in defect concentration in insulators is well established [1–3]. The underlying premise leading to the emission of TL is that exposure of a material to ionizing radiation causes a redistribution of charge in defect centres within the material. When the material is heated at a controlled linear rate, the thermoluminescence is emitted as a temperature-dependent set of peaks collectively known as a glow-curve. The shape and intensity of each of the glow-peaks may be characterized by a set of parameters consisting of the activation energy E, the frequency factors, the number of electrons n0 trapped in defect centres at the start of the heating, and the order of kinetics b. The order of kinetics b is an indication of the retrapping probability i.e. the probability that a free electron from the conduction band will be retrapped rather than recombine with a hole at a recombination centre to produce thermoluminescence. Retrapping of electrons reduces the TL intensity at any particular temperature during the heating process. The physical mechanisms of TL associated with a given glow curve are unique and may be characterized by analysis of the glow-curve for the said kinetic parameters.
- Full Text:
- Date Issued: 2006
Actor/actant-network theory as emerging methodology for environmental education research in southern Africa
- Authors: Nhamo, Godwell
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/373553 , vital:66701 , xlink:href="https://www.ajol.info/index.php/sajee/article/view/122722"
- Description: This paper deliberates on actor/actant-network theory (AANT) as methodology for policy research in environmental education (EE). Insights are drawn from work that applied AANT to research environmental policy processes surrounding the formulation and implementation of South Africa’s Plastic Bags Regulations of 2003. The paper reveals that the application of AANT methodology made it possible to trace relationships, actors, actants and actor/actant-networks surrounding the Plastic Bags Regulations as quasi-object (token). The methodology also enabled a focus on understanding and investigating tensions, debates and responses emerging from the policy process. The findings were that after the promulgation of the first draft of the Plastic Bags Regulations in May 2000, tensions emerged around the nature of regulation (whether to use the command and control approach – preferred by Organised Government – or self regulation – preferred by Organised Business and Organised Labour). From these findings, a series of conceptual frameworks were drawn up as identified around key actors and actor/actant-networks. The conceptual frameworks included among them, Organised Government, Organised Business and Organised Labour.
- Full Text: false
- Date Issued: 2006
- Authors: Nhamo, Godwell
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/373553 , vital:66701 , xlink:href="https://www.ajol.info/index.php/sajee/article/view/122722"
- Description: This paper deliberates on actor/actant-network theory (AANT) as methodology for policy research in environmental education (EE). Insights are drawn from work that applied AANT to research environmental policy processes surrounding the formulation and implementation of South Africa’s Plastic Bags Regulations of 2003. The paper reveals that the application of AANT methodology made it possible to trace relationships, actors, actants and actor/actant-networks surrounding the Plastic Bags Regulations as quasi-object (token). The methodology also enabled a focus on understanding and investigating tensions, debates and responses emerging from the policy process. The findings were that after the promulgation of the first draft of the Plastic Bags Regulations in May 2000, tensions emerged around the nature of regulation (whether to use the command and control approach – preferred by Organised Government – or self regulation – preferred by Organised Business and Organised Labour). From these findings, a series of conceptual frameworks were drawn up as identified around key actors and actor/actant-networks. The conceptual frameworks included among them, Organised Government, Organised Business and Organised Labour.
- Full Text: false
- Date Issued: 2006
Actor/actant-network theory as emerging methodology for environmental education research in southern Africa
- Authors: Nhamo, Godwell
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/373537 , vital:66702 , xlink:href="https://www.ajol.info/index.php/sajee/article/view/122722"
- Description: This paper deliberates on actor/actant-network theory (AANT) as methodology for policy research in environmental education (EE). Insights are drawn from work that applied AANT to research environmental policy processes surrounding the formulation and implementation of South Africa’s Plastic Bags Regulations of 2003. The paper reveals that the application of AANT methodology made it possible to trace relationships, actors, actants and actor/actant-networks surrounding the Plastic Bags Regulations as quasi-object (token). The methodology also enabled a focus on understanding and investigating tensions, debates and responses emerging from the policy process. The findings were that after the promulgation of the first draft of the Plastic Bags Regulations in May 2000, tensions emerged around the nature of regulation (whether to use the command and control approach – preferred by Organised Government – or self regulation – preferred by Organised Business and Organised Labour). From these findings, a series of conceptual frameworks were drawn up as identified around key actors and actor/actant-networks. The conceptual frameworks included among them, Organised Government, Organised Business and Organised Labour.
- Full Text:
- Date Issued: 2006
- Authors: Nhamo, Godwell
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/373537 , vital:66702 , xlink:href="https://www.ajol.info/index.php/sajee/article/view/122722"
- Description: This paper deliberates on actor/actant-network theory (AANT) as methodology for policy research in environmental education (EE). Insights are drawn from work that applied AANT to research environmental policy processes surrounding the formulation and implementation of South Africa’s Plastic Bags Regulations of 2003. The paper reveals that the application of AANT methodology made it possible to trace relationships, actors, actants and actor/actant-networks surrounding the Plastic Bags Regulations as quasi-object (token). The methodology also enabled a focus on understanding and investigating tensions, debates and responses emerging from the policy process. The findings were that after the promulgation of the first draft of the Plastic Bags Regulations in May 2000, tensions emerged around the nature of regulation (whether to use the command and control approach – preferred by Organised Government – or self regulation – preferred by Organised Business and Organised Labour). From these findings, a series of conceptual frameworks were drawn up as identified around key actors and actor/actant-networks. The conceptual frameworks included among them, Organised Government, Organised Business and Organised Labour.
- Full Text:
- Date Issued: 2006
African Coelacanth Ecosystem Programme: An overview of the conference contributions
- Ribbink, Anthony J, Roberts, Michael J
- Authors: Ribbink, Anthony J , Roberts, Michael J
- Date: 2006
- Language: English
- Type: text , Article
- Identifier: vital:7127 , http://hdl.handle.net/10962/d1010637
- Description: Latimeria chalumnae is the icon for the multidisciplinary, multinational African Coelacanth Ecosystem Programme (ACEP) dedicated to improving the understanding of biological and other processes that support marine life. This article provides an overview of contributions made at a conference hosted by ACEP at the end of 2003. It also reviews significant developments regarding coelacanth conservation which have taken place since the conference. Delegates at the meeting concluded that the integrated regional,ecosystem approach that had been adopted by ACEP should continue. Underwater observation and exploration, however, should be supplemented by more experimental and technical analyses in order to answer longstanding questions related to coelacanths and other organisms.
- Full Text:
- Date Issued: 2006
- Authors: Ribbink, Anthony J , Roberts, Michael J
- Date: 2006
- Language: English
- Type: text , Article
- Identifier: vital:7127 , http://hdl.handle.net/10962/d1010637
- Description: Latimeria chalumnae is the icon for the multidisciplinary, multinational African Coelacanth Ecosystem Programme (ACEP) dedicated to improving the understanding of biological and other processes that support marine life. This article provides an overview of contributions made at a conference hosted by ACEP at the end of 2003. It also reviews significant developments regarding coelacanth conservation which have taken place since the conference. Delegates at the meeting concluded that the integrated regional,ecosystem approach that had been adopted by ACEP should continue. Underwater observation and exploration, however, should be supplemented by more experimental and technical analyses in order to answer longstanding questions related to coelacanths and other organisms.
- Full Text:
- Date Issued: 2006
Alternative media: a viable option for Southern Africa?
- Authors: Banda, Fackson
- Date: 2006
- Language: English
- Type: text , article
- Identifier: vital:6328 , http://hdl.handle.net/10962/d1008473 , https://core.ac.uk/download/pdf/145046852.pdf
- Description: preprint , The article attempts a historically and culturally based definition of alternative media. It then gives some case studies to illustrate the efficacy of such media forms, apart from highlighting the problems associated with them. It concludes that alternative media emerge to deal with specific ideological projects and, as such, must be viewed as satisfying a specific need at a specific point in time.
- Full Text:
- Date Issued: 2006
- Authors: Banda, Fackson
- Date: 2006
- Language: English
- Type: text , article
- Identifier: vital:6328 , http://hdl.handle.net/10962/d1008473 , https://core.ac.uk/download/pdf/145046852.pdf
- Description: preprint , The article attempts a historically and culturally based definition of alternative media. It then gives some case studies to illustrate the efficacy of such media forms, apart from highlighting the problems associated with them. It concludes that alternative media emerge to deal with specific ideological projects and, as such, must be viewed as satisfying a specific need at a specific point in time.
- Full Text:
- Date Issued: 2006
AmaNdebele, Peter Magubane and Sandra Klopper: book review
- Authors: Simbao, Ruth K
- Date: 2006
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/147336 , vital:38627 , https://0-hdl.handle.net.wam.seals.ac.za/10520/EJC31002
- Description: AmaNdebele is a very attractive book with beautifully reproduced colour photographs taken by the renowned photographer Peter Magubane, who secured enormous credibility as a photojournalist during the violent years of apartheid. While some South African readers who browse through the glossy portrayals of ceremonial attire and homestead decorations may recall Magubane's earlier books such as Soweto speaks (1981) and Soweto: The fruit of fear (1986) in which the photographer laid bare the ferocious violence of apartheid rule, many readers will skip over the nuances of both Magubane's disrupted career and the contentious relationship between the Ndebele people and the South African apartheid government.
- Full Text:
- Date Issued: 2006
- Authors: Simbao, Ruth K
- Date: 2006
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/147336 , vital:38627 , https://0-hdl.handle.net.wam.seals.ac.za/10520/EJC31002
- Description: AmaNdebele is a very attractive book with beautifully reproduced colour photographs taken by the renowned photographer Peter Magubane, who secured enormous credibility as a photojournalist during the violent years of apartheid. While some South African readers who browse through the glossy portrayals of ceremonial attire and homestead decorations may recall Magubane's earlier books such as Soweto speaks (1981) and Soweto: The fruit of fear (1986) in which the photographer laid bare the ferocious violence of apartheid rule, many readers will skip over the nuances of both Magubane's disrupted career and the contentious relationship between the Ndebele people and the South African apartheid government.
- Full Text:
- Date Issued: 2006
An Exploration of How Natural Resource Management (NRM) Discourse is Integrated into Key Pedagogic Texts
- Authors: Nsubuga, Yvonne
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/373552 , vital:66703 , xlink:href="https://www.ajol.info/index.php/sajee/article/view/122753"
- Description: Natural resource management (NRM) education has the potential to improve the quality and relevance of rural education in South Africa. For this potential to be realised, the various educational resources that are commonly used by teachers and learners in rural schools need to incorporate natural resource management knowledge. Using Bernstein’s concepts of classification and his theories on recontextualisation, a content analysis study was carried out to compare the level of NRM integration within the Grade 10 Life Sciences syllabus, and a Grade 10 Life Sciences textbook. Results from the analysis of the syllabus showed that overall only 9% of all the knowledge statements analysed had a strong link to NRM and related issues. The highest percentage of such sentences was found in the Core Knowledge section of the syllabus (21%). For the textbook, only 8% of the analysed items had a strong link to NRM and related issues, with the highest percentage of such items occurring in the Suggested Activities section (16%). However, the level of NRM integration in both documents increased considerably when sentences that had only an implicit link to NRM and related issues were included. It was concluded that both documents provide ample opportunities for NRM learning, although the extent to which this occurs varies among their different sections. The recontextualising role of the Grade 10 Life Sciences textbook was reflected in its relatively higher level of NRM integration in the Suggested Activities category, and in the Glossary category. This study highlights the need for further strengthening of the position of NRM within the Grade 10 Life Sciences syllabus, and for more Bernstein-based research to inform South Africa’s curriculum reform initiatives in environmental education.
- Full Text:
- Date Issued: 2006
- Authors: Nsubuga, Yvonne
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/373552 , vital:66703 , xlink:href="https://www.ajol.info/index.php/sajee/article/view/122753"
- Description: Natural resource management (NRM) education has the potential to improve the quality and relevance of rural education in South Africa. For this potential to be realised, the various educational resources that are commonly used by teachers and learners in rural schools need to incorporate natural resource management knowledge. Using Bernstein’s concepts of classification and his theories on recontextualisation, a content analysis study was carried out to compare the level of NRM integration within the Grade 10 Life Sciences syllabus, and a Grade 10 Life Sciences textbook. Results from the analysis of the syllabus showed that overall only 9% of all the knowledge statements analysed had a strong link to NRM and related issues. The highest percentage of such sentences was found in the Core Knowledge section of the syllabus (21%). For the textbook, only 8% of the analysed items had a strong link to NRM and related issues, with the highest percentage of such items occurring in the Suggested Activities section (16%). However, the level of NRM integration in both documents increased considerably when sentences that had only an implicit link to NRM and related issues were included. It was concluded that both documents provide ample opportunities for NRM learning, although the extent to which this occurs varies among their different sections. The recontextualising role of the Grade 10 Life Sciences textbook was reflected in its relatively higher level of NRM integration in the Suggested Activities category, and in the Glossary category. This study highlights the need for further strengthening of the position of NRM within the Grade 10 Life Sciences syllabus, and for more Bernstein-based research to inform South Africa’s curriculum reform initiatives in environmental education.
- Full Text:
- Date Issued: 2006
Application of reverse-flow micellar electrokinetic chromatography for the simultaneous determination of flavonols and terpene trilactones in Ginkgo biloba dosage forms
- Dubber, Mary-Jean, Kanfer, Isadore
- Authors: Dubber, Mary-Jean , Kanfer, Isadore
- Date: 2006
- Language: English
- Type: text , Article
- Identifier: vital:6357 , http://hdl.handle.net/10962/d1006049
- Description:
A reverse-flow micellar electrokinetic chromatographic (RF-MEKC) method was developed for the simultaneous qualitative determination of 10 components consisting of the flavonol glycosides, rutin and quercitrin, the flavonol aglycones, isorhamnetin, kaempferol and quercetin, the terpene trilactones, ginkgolides A, B, C and J and the sesquiterpene, bilobalide. This method was used to fingerprint Ginkgo biloba solid oral dosage forms and validated for the quantitation of the marker compounds, rutin and quercetin in some commercial products. In addition to the usual variables, the influence of some essential background electrolyte (BGE) components such as sodium dodecyl sulphate (SDS) and
-cyclodextrin concentrations were investigated. A polyimide fused-silica square capillary column (75 μm I.D. × 360 μm O.D.) with a total length of 60.0 cm and effective length of 45.0 cm was used for the separation. The final BGE consisted of 20 mM phosphoric acid, 40 mM SDS and 12 mM -cyclodextrin (pH 2.2) using reverse polarity with a voltage of −17.5 kV. Samples were injected electrokinetically at −5 kV for 3 s for the qualitative analysis and hydrodynamically at 20 mbar for 0.6 s for the quantitative assay. The total run time was 22 min and the limits of detection were 3.13 μg/ml and 1.88 μg/ml for rutin and quercetin, respectively. Fingerprint profiles of the solid oral dosage forms and the results of the quantitative analysis indicated that there were major discrepancies in the marker content between products and illustrates the value of this method for use as a procedure to assess product quality of commercially available Ginkgo biloba products. - Full Text:
- Date Issued: 2006
- Authors: Dubber, Mary-Jean , Kanfer, Isadore
- Date: 2006
- Language: English
- Type: text , Article
- Identifier: vital:6357 , http://hdl.handle.net/10962/d1006049
- Description:
A reverse-flow micellar electrokinetic chromatographic (RF-MEKC) method was developed for the simultaneous qualitative determination of 10 components consisting of the flavonol glycosides, rutin and quercitrin, the flavonol aglycones, isorhamnetin, kaempferol and quercetin, the terpene trilactones, ginkgolides A, B, C and J and the sesquiterpene, bilobalide. This method was used to fingerprint Ginkgo biloba solid oral dosage forms and validated for the quantitation of the marker compounds, rutin and quercetin in some commercial products. In addition to the usual variables, the influence of some essential background electrolyte (BGE) components such as sodium dodecyl sulphate (SDS) and
-cyclodextrin concentrations were investigated. A polyimide fused-silica square capillary column (75 μm I.D. × 360 μm O.D.) with a total length of 60.0 cm and effective length of 45.0 cm was used for the separation. The final BGE consisted of 20 mM phosphoric acid, 40 mM SDS and 12 mM -cyclodextrin (pH 2.2) using reverse polarity with a voltage of −17.5 kV. Samples were injected electrokinetically at −5 kV for 3 s for the qualitative analysis and hydrodynamically at 20 mbar for 0.6 s for the quantitative assay. The total run time was 22 min and the limits of detection were 3.13 μg/ml and 1.88 μg/ml for rutin and quercetin, respectively. Fingerprint profiles of the solid oral dosage forms and the results of the quantitative analysis indicated that there were major discrepancies in the marker content between products and illustrates the value of this method for use as a procedure to assess product quality of commercially available Ginkgo biloba products. - Full Text:
- Date Issued: 2006
Atlas of Southern African freshwater fishes
- Scott, L E P, Skelton, P H, Booth, A J, Verheust, L, Dooley, J, Harris, R
- Authors: Scott, L E P , Skelton, P H , Booth, A J , Verheust, L , Dooley, J , Harris, R
- Date: 2006
- Subjects: Freshwater fishes -- South Africa , Freshwater fishes -- Africa, Southern , Freshwater fishes -- Africa, Southern -- Identification
- Language: English
- Type: text , book
- Identifier: http://hdl.handle.net/10962/199097 , vital:46068
- Description: Worldwide concern over the loss of biological diversity during the past decade has provided the impetus for the development of biodiversity databases and biological atlas projects in order to make information accessible. This Geographic Information Systems-based Atlas of Southern African Freshwater Fishes is the first of its kind for fishes in Africa and, as such, can be seen as contributing towards this global trend of consolidation and refining of biodiversity information. The technological advances made in computing systems over the past decade have facilitated the extraction and utilisation of much of the untapped information in museum collections. The size of most natural history collections had tended to prohibit any comprehensive applied use of the specimens on a large scale, but the computerisation of these collections has proved to be an invaluable tool to systematists, taxonomists and ecologists, by allowing faster and more efficient access to specimen record data of interest. With the automation of many biological databases, public attention has been brought to their potential contribution to biodiversity studies and conservation efforts around the world. The application of Geographic Information Systems (GIS) in the field of southern African ichthyology and freshwater fisheries management has been limited, until now, by the lack of good-quality, comprehensive data sets, adequate budgets and GIS skills. Sophisticated investigations of fish distributions for conservation and management purposes need a powerful computing platform. This is realised in the Atlas of Southern African Freshwater Fishes, which has been tested and used for biogeographic analysis in the southern African region. The atlas was established using specimen records from nineteen museum collections, and currently contains 35145 geo-referenced specimen records, collected between 1885 and 2000 in eleven countries of southern Africa, which represent 254 fish species from 37 families. The Atlas of Southern African Freshwater Fishes was developed with the objective of being a dynamic, powerful information system. It has been constructed to allow the import of additional information at any stage, and it is designed to be as accessible and as user-friendly as current technology allows. This Atlas is the product of the successful integration of fish distributional information with other spatial data layers to provide a new tool for the study of freshwater fish in southern Africa.
- Full Text:
- Date Issued: 2006
- Authors: Scott, L E P , Skelton, P H , Booth, A J , Verheust, L , Dooley, J , Harris, R
- Date: 2006
- Subjects: Freshwater fishes -- South Africa , Freshwater fishes -- Africa, Southern , Freshwater fishes -- Africa, Southern -- Identification
- Language: English
- Type: text , book
- Identifier: http://hdl.handle.net/10962/199097 , vital:46068
- Description: Worldwide concern over the loss of biological diversity during the past decade has provided the impetus for the development of biodiversity databases and biological atlas projects in order to make information accessible. This Geographic Information Systems-based Atlas of Southern African Freshwater Fishes is the first of its kind for fishes in Africa and, as such, can be seen as contributing towards this global trend of consolidation and refining of biodiversity information. The technological advances made in computing systems over the past decade have facilitated the extraction and utilisation of much of the untapped information in museum collections. The size of most natural history collections had tended to prohibit any comprehensive applied use of the specimens on a large scale, but the computerisation of these collections has proved to be an invaluable tool to systematists, taxonomists and ecologists, by allowing faster and more efficient access to specimen record data of interest. With the automation of many biological databases, public attention has been brought to their potential contribution to biodiversity studies and conservation efforts around the world. The application of Geographic Information Systems (GIS) in the field of southern African ichthyology and freshwater fisheries management has been limited, until now, by the lack of good-quality, comprehensive data sets, adequate budgets and GIS skills. Sophisticated investigations of fish distributions for conservation and management purposes need a powerful computing platform. This is realised in the Atlas of Southern African Freshwater Fishes, which has been tested and used for biogeographic analysis in the southern African region. The atlas was established using specimen records from nineteen museum collections, and currently contains 35145 geo-referenced specimen records, collected between 1885 and 2000 in eleven countries of southern Africa, which represent 254 fish species from 37 families. The Atlas of Southern African Freshwater Fishes was developed with the objective of being a dynamic, powerful information system. It has been constructed to allow the import of additional information at any stage, and it is designed to be as accessible and as user-friendly as current technology allows. This Atlas is the product of the successful integration of fish distributional information with other spatial data layers to provide a new tool for the study of freshwater fish in southern Africa.
- Full Text:
- Date Issued: 2006
Benthic mapping using local aerial photo interpretation and resident taxa inventories for designing marine protected areas
- Shankar, Aswani, Lauer, Matthew
- Authors: Shankar, Aswani , Lauer, Matthew
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/439059 , vital:73541 , xlink:href="https://doi.org/10.1017/S0376892906003183"
- Description: Given the frequent socioeconomic, political and concomitant ecological failures of science-driven marine protected area (MPA) programmes, it is now important to design MPAs by integrating natural and social science research more comprehensively. This study shows how indigenous peoples assisted in the design of MPAs by identifying marine substrates and related resident taxa on aerial photos, information which was then incorporated into a geographical information system (GIS) database, along with dive survey data. Two questions were asked: (1) Is indigenous ecological knowledge accurate enough for mapping the benthos and associated taxa? (2) Is such an approach an appropriate way for assisting in the biological and social design of MPAs in Oceania? Conventional quadrat field dive surveys were used to measure the accuracy of substrate identification by local informants and a visual survey was used to test hypotheses formulated from local knowledge regarding the spatial distribution and relative abundance of non-cryptic species within certain benthic habitats. Equivalence rates between indigenous aerial photo interpretations of dominant benthic substrates and in situ dive surveys were 75–85% for a moderately detailed classification scheme of the benthos, which included nine locally-defined abiotic and biotic benthic classes for the MPA seabed. Similarly, the taxa inventory showed a strong correspondence between the qualitative predictions of local fisherfolk and the quantitative analysis of non-cryptic species distribution, including their relative abundance and geophysical locations. Indigenous people's predictions about the presence or absence of fish in different benthic habitats corresponded 77% and 92% of the time (depending on scoring schema) with in situ visual measurements. These results demonstrate how incorporating local knowledge of benthic heterogeneity, existing biological communities, and particular spatio-temporal events of biological significance into a GIS database can corroborate the production of scientifically reliable base resource maps for designing MPAs in an environmentally and culturally sound fashion. This participatory approach was used to design and then establish MPAs in the Roviana and Vonavona region of the Western Solomon Islands. Under appropriate conditions, interdisciplinary work can complement the design of scientific fishery management and biodiversity conservation prescriptions for coastal Oceania.
- Full Text:
- Date Issued: 2006
- Authors: Shankar, Aswani , Lauer, Matthew
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/439059 , vital:73541 , xlink:href="https://doi.org/10.1017/S0376892906003183"
- Description: Given the frequent socioeconomic, political and concomitant ecological failures of science-driven marine protected area (MPA) programmes, it is now important to design MPAs by integrating natural and social science research more comprehensively. This study shows how indigenous peoples assisted in the design of MPAs by identifying marine substrates and related resident taxa on aerial photos, information which was then incorporated into a geographical information system (GIS) database, along with dive survey data. Two questions were asked: (1) Is indigenous ecological knowledge accurate enough for mapping the benthos and associated taxa? (2) Is such an approach an appropriate way for assisting in the biological and social design of MPAs in Oceania? Conventional quadrat field dive surveys were used to measure the accuracy of substrate identification by local informants and a visual survey was used to test hypotheses formulated from local knowledge regarding the spatial distribution and relative abundance of non-cryptic species within certain benthic habitats. Equivalence rates between indigenous aerial photo interpretations of dominant benthic substrates and in situ dive surveys were 75–85% for a moderately detailed classification scheme of the benthos, which included nine locally-defined abiotic and biotic benthic classes for the MPA seabed. Similarly, the taxa inventory showed a strong correspondence between the qualitative predictions of local fisherfolk and the quantitative analysis of non-cryptic species distribution, including their relative abundance and geophysical locations. Indigenous people's predictions about the presence or absence of fish in different benthic habitats corresponded 77% and 92% of the time (depending on scoring schema) with in situ visual measurements. These results demonstrate how incorporating local knowledge of benthic heterogeneity, existing biological communities, and particular spatio-temporal events of biological significance into a GIS database can corroborate the production of scientifically reliable base resource maps for designing MPAs in an environmentally and culturally sound fashion. This participatory approach was used to design and then establish MPAs in the Roviana and Vonavona region of the Western Solomon Islands. Under appropriate conditions, interdisciplinary work can complement the design of scientific fishery management and biodiversity conservation prescriptions for coastal Oceania.
- Full Text:
- Date Issued: 2006
Bioequivalence assessment of generic products an innovative South African approach
- Walker, Roderick B, Kanfer, Isadore, Skinner, Michael F
- Authors: Walker, Roderick B , Kanfer, Isadore , Skinner, Michael F
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/184256 , vital:44194 , xlink:href="https://doi.org/10.1080/10601330500534014"
- Description: Concurrent with the implementation of new legislation mandating Generic Substitution in South Africa, a new set of guidelines for bioavailability and bioequivalence have been published. Since one of the main objectives of the new legislation in South Africa relating to Generic Substitution is to ensure that medicines of high quality, safety, and efficacy are made more accessible and more affordable to the wider public, the need to speed up approval of such multi-source products has become a regulatory priority. In order to facilitate this process, various bioequivalence issues have been addressed including important issues such as the acceptance criteria and associated bioequivalence intervals, use of a foreign reference product and the issue of assessing highly variable drugs (HVDs). In addition, dispensations have been made with respect to food effect assessment and variability relating to genetic polymorphism in drug metabolism (genotyping/phenotyping). Furthermore, the use of “old” biostudies submitted in support of an application is subject to expiry date. Acceptance of appropriate data requires that specific criteria such as Cmax and AUC, in addition to the usual considerations, also meet the limits specified by the particular registration authority of the country where such products are intended to be marketed. Generally, these limits require that the 90% confidence interval (CI) for AUC and Cmax test/reference ratios lies within the acceptance interval of 0.80–1.25 calculated using log-transformed data. While such acceptance criteria are, in general, ubiquitous, some differences in acceptance criteria do exist between various countries. The new guidelines for bioavailability/bioequivalence studies developed by the South African regulatory authority, the Medicines Control Council (MCC), makes provision for highly variable drugs and the use of a non-South African reference product. The MCC requires that the acceptance criterion for Cmax ratios be set at 0.75–1.33 while maintaining AUC ratios at 0.80–1.25 using a 90% CI. Furthermore, provision is made to apply scaling based on average bioequivalence assessment and, as an interim measure, consideration has also been given to the use of a foreign reference product provided that equivalence between that product and the innovator product currently available on the South African market can be shown using in vitro testing.
- Full Text:
- Date Issued: 2006
- Authors: Walker, Roderick B , Kanfer, Isadore , Skinner, Michael F
- Date: 2006
- Subjects: To be catalogued
- Language: English
- Type: text , article
- Identifier: http://hdl.handle.net/10962/184256 , vital:44194 , xlink:href="https://doi.org/10.1080/10601330500534014"
- Description: Concurrent with the implementation of new legislation mandating Generic Substitution in South Africa, a new set of guidelines for bioavailability and bioequivalence have been published. Since one of the main objectives of the new legislation in South Africa relating to Generic Substitution is to ensure that medicines of high quality, safety, and efficacy are made more accessible and more affordable to the wider public, the need to speed up approval of such multi-source products has become a regulatory priority. In order to facilitate this process, various bioequivalence issues have been addressed including important issues such as the acceptance criteria and associated bioequivalence intervals, use of a foreign reference product and the issue of assessing highly variable drugs (HVDs). In addition, dispensations have been made with respect to food effect assessment and variability relating to genetic polymorphism in drug metabolism (genotyping/phenotyping). Furthermore, the use of “old” biostudies submitted in support of an application is subject to expiry date. Acceptance of appropriate data requires that specific criteria such as Cmax and AUC, in addition to the usual considerations, also meet the limits specified by the particular registration authority of the country where such products are intended to be marketed. Generally, these limits require that the 90% confidence interval (CI) for AUC and Cmax test/reference ratios lies within the acceptance interval of 0.80–1.25 calculated using log-transformed data. While such acceptance criteria are, in general, ubiquitous, some differences in acceptance criteria do exist between various countries. The new guidelines for bioavailability/bioequivalence studies developed by the South African regulatory authority, the Medicines Control Council (MCC), makes provision for highly variable drugs and the use of a non-South African reference product. The MCC requires that the acceptance criterion for Cmax ratios be set at 0.75–1.33 while maintaining AUC ratios at 0.80–1.25 using a 90% CI. Furthermore, provision is made to apply scaling based on average bioequivalence assessment and, as an interim measure, consideration has also been given to the use of a foreign reference product provided that equivalence between that product and the innovator product currently available on the South African market can be shown using in vitro testing.
- Full Text:
- Date Issued: 2006