Abstract
Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations serves as a comprehensive reference guide that describes the nonclinical regulatory requirements guiding drug development as promulgated by the specific region involved in the submission. The book further delves into the testing requirements, both scientific and technical, for a number of the disciplines that comprise nonclinical evaluations. This 465-page hardback is an update from a previously published book by Alder and Zbinden (1988) addressing similar topics, however, prior to modernization of many of the testing requirements. The book is divided into 2 parts; part 1 is comprised of 11 chapters, each discussing the regional regulatory requirements for nonclinical drug development following implementation of the ICH guidelines and more recent maturation of regional requirements. Part 2 is an informative update on specific areas of consideration, which drive the nonclinical testing programs dictated by the regulatory requirements.
Chapter 1 is a good introduction that speaks to the strategies used for drug development and the hurdles that need to be addressed in bringing a drug to market. Chapter 2 is a summary of the process that drove the inception of the International Congress on Harmonization (ICH) including the responsibilities of the expert working groups and the various steps involved in the implementation of the guidance. The next 9 chapters specifically address the regional requirement for nonclinical drug development necessary to conduct in support of the clinical program. These regions include the United States (chapter 3), Brazil, and the Sothern Common Market known as MERCOSUR (chapter 4), Canada (chapter 5), Europe (chapter 6), South Africa (chapter 7), Asia Pacific: China (chapter 8), Japan (chapter 9), India (chapter 10), and Asia Pacific: Australia (chapter 11). Each chapter is well organized, very comprehensive, and discusses the regulatory scientific requirements necessary to address prior to gaining acceptance in that particular region. The information contained in these chapters recognizes the fact that drug development, and eventual marketing of therapeutics, often encompasses multiple regulatory authorities and that success is often measured by the ability to maneuver the regional legislative requirements based on knowledge, appreciation of regional differences, and acceptance that circumvention is often not a successful strategy. The subject matter experts that contributed to these chapters were excellent choices and I personally learned quite a lot from reviewing the information.
Part II of the book delves into the specific scientific requirements involved in addressing the technical aspects and scientific conduct of nonclinical studies, insight into the genesis of the changes frequently encountered during a nonclinical study, and the interpretation of the results. The 10 chapters comprising part II includes Repeat Dose Toxicology Studies (chapter 12), Evaluation of Potential Carcinogenicity (chapter 13), Genetic Toxicology (chapter 14), Developmental and Reproductive Toxicology (chapter 15), Juvenile Animal Toxicology Studies (chapter 16), Immunotoxicology (chapter 17), Biotechnology-Derived Pharmaceuticals (chapter 18), Vaccine Development (chapter 19), Phototoxicity and Photocarcinogenicity (chapter 20), and Degradants, Impurities, Excipients and Metabolites (chapter 21). Similar to part I of the book, each of these chapters contain the most recent and relevant information addressing each of these nonclinical disciplines written by true experts in the field. Each chapter serves as a terrific reference providing the scientific team with the background and specific considerations that should be discussed prior to embarking on a development program. This material is needed by the Study Director or Principle Investigator and should be shared among the development team members.
In summary, Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations is an excellent reference text that would be quite helpful for anyone working in nonclinical drug development, especially the regulatory toxicologist and others involved in negotiating the science and regulations dictating approval of drugs. The information is up to date, well presented, and written to an appropriate level of understanding. The contributing authors are recognized in their respective fields and leaders in the disciplines that they have addressed. The book serves as a good resource to provide the scientist with sufficient background in regional regulatory requirements, a diversity of testing paradigms, and some guidance into the interpretation of results and development of strategy for continued drug development. A good reference book to have on your shelf.