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Biotechnology and safety assessment
258
Book Reviews~Biochemical Education 26 (1998) 252-259
PII: S0307- 4412(97)00029-0
Dental Enamel E d i t e d by H C Slavkin. p p 284. J o h n W i l e y & Sons, Chichester. 1997. £55 I S B N 0-471-96872-2 This book provides a compilation of lectures describing current thinking on the molecular mechanisms underlying the development of dental enamel. Of particular interest is the chapter on Tooth Morphogenesis by Theslef and Aberg in which they describe their work to elucidate the specific action of growth factors as inductive signals of tooth development. Also the chapters describing the molecular pathology of inherited enamel defects and amelogenin gene expression demonstrate the increasing application of molecular biological approaches to dental research. This book must represent an essential read, not only for both those teaching the subject to undergraduates, but also those with an active research interest in the area. P A Robinson
PII: S0307- 4412(98)00087-9
Biotechnology and Safety Assessment E d i t e d by J o h n A T h o m a s a n d L a u r i e A Myers. p p 270. R a v e n Press, N e w York. 1993. I S B N 0-7817-0080-9 This is a useful book which provides a concise, readable, well presented summary of the safety assessment of biotechnology products in the area of therapeutic agents. The diagrams and tables are particularly useful and it provides readers with a good modern overview of the subject. It will be excellent for final year undergraduate and postgraduate students in this area, whilst the comprehensive bibliographies at the end of each chapter make it a valuable starting point for all who wish or need to understand the problems of safety assessment in biotechnology. The book consists of a series of eleven chapters on a well selected range of topics written by industrial or academic scientists. The authors of all the chapters bar one are US based and hence the discussion of regulatory aspects is almost entirely from a US perspective. Whilst this is not a serious problem when considering drug safety regulation, it is more significant when considering the regulation of biotechnology activity itself. In fairness to the authors, they do not seem to have intended to cover this as such. It is a weakness in the chapter on the safety evaluation of genetically engineered plants and plant products, written with particular reference to insect-resistant cotton by Monsanto scientists. This chapter outlines the US regulatory philosophy as expressed in the 1992 F D A statement of policy, but there is no discussion of the use of antibiotic resistance markers and the evaluation of the environmental impact of genetically modified crop plants. These are areas of concern and represent a significant lacuna in this section. A chapter on safety approaches and regulations with regard to biotechnology derived foods is written by European authors, from the W H O European Centre for Environmental Health, and the outline of the scheme of the decision-tree approach for safety evaluation of novel foods is
helpful. The book was published before the recent European Union regulatory activity in this area which needs to be considered. The main body of the text deals with the safety evaluation of therapeutic products and is generally up to date. The opening chapter on the development, safety and efficacy of 'New Biologics' reviews the field and the range of therapeutics involved, with a summary of the quality assurance requirements for each stage in the development and testing of hybridoma products. Subsequent chapters discuss the safety assessment of biotechnology products and the toxicology and evaluation of biotechnology-derived proteins with specific consideration of such things as the evaluative tests for insulin, the F D A basis for approval of rHGH, rtPA recommended toxicity testing and toxicological studies in animals for monoclonal antibodies. The clinical pharmacology and development of human biological agents, drug delivery systems and recombinant proteins, concepts of gene therapy and genetic diseases, transgenic animal models and genetically altered species are well reviewed also. A chapter on the biotransformation of Xenobiotics is sound, but unexciting and would profit more from discussion of toxic effects of reactive intermediates and radical species. The chapter on the relative roles of in vitro and in vivo toxicology by Shayne Gad was particularly interesting. He emphasises that to the familiar three Rs of Replacement, Reduction and Refinement (of animal usage) must be added the fourth R - - Responsibility. This is the Cardinal R for toxicologists who are personally committed to minimise animal use and suffering but who have a responsibility to ensure the safety of people using or exposed to drugs and chemical produced in our Society. He correctly emphasises the value of 'in vitro' methods in minimising development times but recognises that intact animal models - - and indeed humans (for pharmaceuticals) - will still be essential elements in the safety assessment armentarium for the foreseeable future. The book recognises that therapeutic and other products of biotechnology should be classified and evaluated by their use and do not constitute a 'separate' community of products for safety assessment purposes. An appendix on animal models of human disease and a glossary complete a work which should be in all bioscience and regulatory libraries. F Dewhurst
PII: S0307-4412(98)00152-6
Microbiology of Fermented Foods E d i t e d by Brian J B W o o d . p p 852. Blackie A c a d e m i c a n d Professional, L o n d o n . 1998. I S B N 0-7514-0216-8 This is the second edition of this work (the first having appeared in 1985) and represents a significant advance on that earlier treatise. This second edition comprises 25 chapters contributed by no fewer than 40 international experts in their particular fields. The text is in two volumes, though this is for convenience in handling as the contents of the volumes are not presented in any organised or cohesive way. There is no apparent rationale as to which chapters appear in which
Book Reviews~Biochemical Education 26 (1998) 252-259
PII: S0307- 4412(97)00029-0
Dental Enamel E d i t e d by H C Slavkin. p p 284. J o h n W i l e y & Sons, Chichester. 1997. £55 I S B N 0-471-96872-2 This book provides a compilation of lectures describing current thinking on the molecular mechanisms underlying the development of dental enamel. Of particular interest is the chapter on Tooth Morphogenesis by Theslef and Aberg in which they describe their work to elucidate the specific action of growth factors as inductive signals of tooth development. Also the chapters describing the molecular pathology of inherited enamel defects and amelogenin gene expression demonstrate the increasing application of molecular biological approaches to dental research. This book must represent an essential read, not only for both those teaching the subject to undergraduates, but also those with an active research interest in the area. P A Robinson
PII: S0307- 4412(98)00087-9
Biotechnology and Safety Assessment E d i t e d by J o h n A T h o m a s a n d L a u r i e A Myers. p p 270. R a v e n Press, N e w York. 1993. I S B N 0-7817-0080-9 This is a useful book which provides a concise, readable, well presented summary of the safety assessment of biotechnology products in the area of therapeutic agents. The diagrams and tables are particularly useful and it provides readers with a good modern overview of the subject. It will be excellent for final year undergraduate and postgraduate students in this area, whilst the comprehensive bibliographies at the end of each chapter make it a valuable starting point for all who wish or need to understand the problems of safety assessment in biotechnology. The book consists of a series of eleven chapters on a well selected range of topics written by industrial or academic scientists. The authors of all the chapters bar one are US based and hence the discussion of regulatory aspects is almost entirely from a US perspective. Whilst this is not a serious problem when considering drug safety regulation, it is more significant when considering the regulation of biotechnology activity itself. In fairness to the authors, they do not seem to have intended to cover this as such. It is a weakness in the chapter on the safety evaluation of genetically engineered plants and plant products, written with particular reference to insect-resistant cotton by Monsanto scientists. This chapter outlines the US regulatory philosophy as expressed in the 1992 F D A statement of policy, but there is no discussion of the use of antibiotic resistance markers and the evaluation of the environmental impact of genetically modified crop plants. These are areas of concern and represent a significant lacuna in this section. A chapter on safety approaches and regulations with regard to biotechnology derived foods is written by European authors, from the W H O European Centre for Environmental Health, and the outline of the scheme of the decision-tree approach for safety evaluation of novel foods is
helpful. The book was published before the recent European Union regulatory activity in this area which needs to be considered. The main body of the text deals with the safety evaluation of therapeutic products and is generally up to date. The opening chapter on the development, safety and efficacy of 'New Biologics' reviews the field and the range of therapeutics involved, with a summary of the quality assurance requirements for each stage in the development and testing of hybridoma products. Subsequent chapters discuss the safety assessment of biotechnology products and the toxicology and evaluation of biotechnology-derived proteins with specific consideration of such things as the evaluative tests for insulin, the F D A basis for approval of rHGH, rtPA recommended toxicity testing and toxicological studies in animals for monoclonal antibodies. The clinical pharmacology and development of human biological agents, drug delivery systems and recombinant proteins, concepts of gene therapy and genetic diseases, transgenic animal models and genetically altered species are well reviewed also. A chapter on the biotransformation of Xenobiotics is sound, but unexciting and would profit more from discussion of toxic effects of reactive intermediates and radical species. The chapter on the relative roles of in vitro and in vivo toxicology by Shayne Gad was particularly interesting. He emphasises that to the familiar three Rs of Replacement, Reduction and Refinement (of animal usage) must be added the fourth R - - Responsibility. This is the Cardinal R for toxicologists who are personally committed to minimise animal use and suffering but who have a responsibility to ensure the safety of people using or exposed to drugs and chemical produced in our Society. He correctly emphasises the value of 'in vitro' methods in minimising development times but recognises that intact animal models - - and indeed humans (for pharmaceuticals) - will still be essential elements in the safety assessment armentarium for the foreseeable future. The book recognises that therapeutic and other products of biotechnology should be classified and evaluated by their use and do not constitute a 'separate' community of products for safety assessment purposes. An appendix on animal models of human disease and a glossary complete a work which should be in all bioscience and regulatory libraries. F Dewhurst
PII: S0307-4412(98)00152-6
Microbiology of Fermented Foods E d i t e d by Brian J B W o o d . p p 852. Blackie A c a d e m i c a n d Professional, L o n d o n . 1998. I S B N 0-7514-0216-8 This is the second edition of this work (the first having appeared in 1985) and represents a significant advance on that earlier treatise. This second edition comprises 25 chapters contributed by no fewer than 40 international experts in their particular fields. The text is in two volumes, though this is for convenience in handling as the contents of the volumes are not presented in any organised or cohesive way. There is no apparent rationale as to which chapters appear in which