Establishing a formulation design space for a generic clobetasol 17- propionate cream using the principles of quality by design
- Fauzee, Ayeshah Fateemah Beebee
- Authors: Fauzee, Ayeshah Fateemah Beebee
- Date: 2014
- Language: English
- Type: Thesis , Doctoral , PhD
- Identifier: vital:20983 , http://hdl.handle.net/10962/5868
- Description: The pharmaceutical industry is global, is highly regulated and is able to achieve reasonable product quality but at high cost with maximum effort. Numerous challenges face the pharmaceutical industry and include a shrinking research pipeline, less innovation, outsourcing, investments, increasing research and development costs, long approval times, growth of the generic industry, failure to understand or analyze manufacturing failure and wastage as high at fifty percent for some pharmaceutical products. An efficient and flexible pharmaceutical sector should be able to consistently produce high quality pharmaceutical products at a reduced cost with minimal waste. As a result, Food and Drug Administration (FDA) and other agencies such as the International Conference on Harmonization (ICH) have embraced a “Quality by Design” (QbD) paradigm and this has become the “desired state” so as to shift manufacturing from being empirical to a science, engineering, and risk based approach. QbD is a systematic approach for the development of high quality pharmaceutical dosage forms that begins with predefined objectives based on the premise that quality must be built into and not tested into a product. QbD together with the establishment of a design space for dosage forms is a fairly new concept and there is limited published data on QbD concepts that report the entire process of identifying Critical Quality Attributes (CQA), design of a formulation and manufacturing process to meet product CQA, understanding the impact of material attributes and process parameters on product CQA, identification and controlling sources of variability in materials and processes that affect the CQA of a product and finally establishing, evaluating and testing a design space using both in vitro and in vivo approaches to assure that a product of consistent quality can always be produced. The objective of these studies was to implement a QbD approach to establish a design space for the development and manufacture of a safe, effective, stable generic formulation containing 0.05% w/w clobetasol 17-propionate (CP) that had similar in vitro and in vivo characteristics to an innovator product, Dermovate® (Sekpharma® Pty Ltd, Sandton, Gauteng, RSA). Such a product would pose a minimal risk of failure when treating severe skin disorders such as seborrhoeic dermatitis, extreme photodermatitis and/or severe psoriasis in HIV/AIDS patients in Southern Africa.
- Full Text:
- Date Issued: 2014
- Authors: Fauzee, Ayeshah Fateemah Beebee
- Date: 2014
- Language: English
- Type: Thesis , Doctoral , PhD
- Identifier: vital:20983 , http://hdl.handle.net/10962/5868
- Description: The pharmaceutical industry is global, is highly regulated and is able to achieve reasonable product quality but at high cost with maximum effort. Numerous challenges face the pharmaceutical industry and include a shrinking research pipeline, less innovation, outsourcing, investments, increasing research and development costs, long approval times, growth of the generic industry, failure to understand or analyze manufacturing failure and wastage as high at fifty percent for some pharmaceutical products. An efficient and flexible pharmaceutical sector should be able to consistently produce high quality pharmaceutical products at a reduced cost with minimal waste. As a result, Food and Drug Administration (FDA) and other agencies such as the International Conference on Harmonization (ICH) have embraced a “Quality by Design” (QbD) paradigm and this has become the “desired state” so as to shift manufacturing from being empirical to a science, engineering, and risk based approach. QbD is a systematic approach for the development of high quality pharmaceutical dosage forms that begins with predefined objectives based on the premise that quality must be built into and not tested into a product. QbD together with the establishment of a design space for dosage forms is a fairly new concept and there is limited published data on QbD concepts that report the entire process of identifying Critical Quality Attributes (CQA), design of a formulation and manufacturing process to meet product CQA, understanding the impact of material attributes and process parameters on product CQA, identification and controlling sources of variability in materials and processes that affect the CQA of a product and finally establishing, evaluating and testing a design space using both in vitro and in vivo approaches to assure that a product of consistent quality can always be produced. The objective of these studies was to implement a QbD approach to establish a design space for the development and manufacture of a safe, effective, stable generic formulation containing 0.05% w/w clobetasol 17-propionate (CP) that had similar in vitro and in vivo characteristics to an innovator product, Dermovate® (Sekpharma® Pty Ltd, Sandton, Gauteng, RSA). Such a product would pose a minimal risk of failure when treating severe skin disorders such as seborrhoeic dermatitis, extreme photodermatitis and/or severe psoriasis in HIV/AIDS patients in Southern Africa.
- Full Text:
- Date Issued: 2014
Fractured solidarities: labour regulation, workplace restructuring, and employment 'flexibility' in Namibia
- Authors: Klerck, Gilton
- Date: 2005
- Subjects: Industrial relations -- Namibia Labor -- Namibia Labor unions -- Namibia Organizational change -- Namibia Labor laws and legislation -- Namibia Casual labor -- Namibia
- Language: English
- Type: Thesis , Doctoral , PhD
- Identifier: vital:3343 , http://hdl.handle.net/10962/d1004898
- Description: A central concern of this thesis is the expansion, distribution and control of 'non-standard' employment in Namibia since independence. The employment relationship has assumed various historical forms under capitalism, each of which corresponds to a specific mode of regulation with distinct structural dynamics. An attempt is made to extend the regulation approach 'downwards' to account for the problem of order in the workplace and to place the employment relationship within its own regulatory framework. The point of departure in this study of the dynamics of labour regulation is the contradictory nature of labour's incorporation, allocation, control and reproduction within the labour market. The employment relationship is never only an economic exchange, but is also mediated through an institutional framework that connects the processes of production and social reproduction, and regulates conflicting interests inside and outside the workplace. This relationship, as critical realists have pointed out, is a product of the indeterminate intersection of several generative structures. The roots of these generative structures can be traced to three sets of social processes: the processes of production and the structuring of labour demand; the processes of social reproduction and the structuring of labour supply; and the forces of regulation. Non-standard employment is viewed as a particular social and spatio-temporal 'fix' for the various regulatory dilemmas generated by the standard employment relationship. This conception underscores the fact that a national system of labour regulation decisively shapes the conditions under which employers are able to casualise a part of their workforce. The differential experience across national boundaries suggests that analytical space needs to be provided for systems of labour market regulation which may either accentuate or moderate pressures for casualisation. Segmentation on the demand side of the labour market is explored through an analysis of the types of non-standard jobs created in different economic sectors. The various forms of employment 'flexibility' tend to vary in importance according to the specific manner in which a firm chooses to compete. Consequently, non-standard employees are distributed in a complex and uneven manner across industrial sectors and the occupational hierarchy, and face a diverse range of possibilities and liabilities that shape their levels and forms of participation in the labour market. By counteracting the homogenisation effects of labour law and collective bargaining, the mobilisation of cheap and disposable labour through non-standard employment contracts allows employers much greater discretion in constructing the wage-effort bargain. With non-standard employment, social and statutory regulation is weak or underdeveloped and hence managerial control is autocratic, with a significant contractual component. Although the changing social composition of the workforce associated with employment 'flexibility' poses serious challenges to the modes of organisation that have long served the labour movement, trade unions in Namibia and elsewhere have been slow to respond to the threats of casualisation. Of concern here, is the extent to which attempts to promote the security of existing union members is compatible with attempts to organise non-standard employees. This thesis shows that the unions have developed a complex amalgam of strategies in their efforts to regulate non-standard employment relationships.
- Full Text:
- Date Issued: 2005
- Authors: Klerck, Gilton
- Date: 2005
- Subjects: Industrial relations -- Namibia Labor -- Namibia Labor unions -- Namibia Organizational change -- Namibia Labor laws and legislation -- Namibia Casual labor -- Namibia
- Language: English
- Type: Thesis , Doctoral , PhD
- Identifier: vital:3343 , http://hdl.handle.net/10962/d1004898
- Description: A central concern of this thesis is the expansion, distribution and control of 'non-standard' employment in Namibia since independence. The employment relationship has assumed various historical forms under capitalism, each of which corresponds to a specific mode of regulation with distinct structural dynamics. An attempt is made to extend the regulation approach 'downwards' to account for the problem of order in the workplace and to place the employment relationship within its own regulatory framework. The point of departure in this study of the dynamics of labour regulation is the contradictory nature of labour's incorporation, allocation, control and reproduction within the labour market. The employment relationship is never only an economic exchange, but is also mediated through an institutional framework that connects the processes of production and social reproduction, and regulates conflicting interests inside and outside the workplace. This relationship, as critical realists have pointed out, is a product of the indeterminate intersection of several generative structures. The roots of these generative structures can be traced to three sets of social processes: the processes of production and the structuring of labour demand; the processes of social reproduction and the structuring of labour supply; and the forces of regulation. Non-standard employment is viewed as a particular social and spatio-temporal 'fix' for the various regulatory dilemmas generated by the standard employment relationship. This conception underscores the fact that a national system of labour regulation decisively shapes the conditions under which employers are able to casualise a part of their workforce. The differential experience across national boundaries suggests that analytical space needs to be provided for systems of labour market regulation which may either accentuate or moderate pressures for casualisation. Segmentation on the demand side of the labour market is explored through an analysis of the types of non-standard jobs created in different economic sectors. The various forms of employment 'flexibility' tend to vary in importance according to the specific manner in which a firm chooses to compete. Consequently, non-standard employees are distributed in a complex and uneven manner across industrial sectors and the occupational hierarchy, and face a diverse range of possibilities and liabilities that shape their levels and forms of participation in the labour market. By counteracting the homogenisation effects of labour law and collective bargaining, the mobilisation of cheap and disposable labour through non-standard employment contracts allows employers much greater discretion in constructing the wage-effort bargain. With non-standard employment, social and statutory regulation is weak or underdeveloped and hence managerial control is autocratic, with a significant contractual component. Although the changing social composition of the workforce associated with employment 'flexibility' poses serious challenges to the modes of organisation that have long served the labour movement, trade unions in Namibia and elsewhere have been slow to respond to the threats of casualisation. Of concern here, is the extent to which attempts to promote the security of existing union members is compatible with attempts to organise non-standard employees. This thesis shows that the unions have developed a complex amalgam of strategies in their efforts to regulate non-standard employment relationships.
- Full Text:
- Date Issued: 2005
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