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Nonclinical Safety Assessment : A Guide to International Pharmaceutical Regulations,9780470745915
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Nonclinical Safety Assessment : A Guide to International Pharmaceutical Regulations

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Providing a comprehensive, international overview of the regulatory requirements for safety assessment for new drug approvals, each chapter in Nonclinical Safety Assessment is written by experts who have direct, firsthand involvement in drug development in the regions where they are located. International coverage includes World Health Organization (WHO) principles and regional variations, including EMEA guidance, U.S. FDA, and Asia-Pacific. The text provides insights into the future of nonclinical drug testing and approval and includes a list of resources such as guidelines, guidance, and authoritative non-governmental publications.

Author Biography

Dr. William J Brock, Brock Scientific Consulting, USA
Dr. Bill Brock is Principal of Brock Scientific Consulting and manages R&D programs for clients in the pharmaceutical, chemical, food and consumer product industries. He is the Past-President of American Board of Toxicology, serves on the Board of Directors for the Academy of Toxicological Sciences and is an Associate Editor for the International Journal of Toxicology. Dr. Brock has served in a leadership capacity in various organizations within the Society of Toxicology, the American College of Toxicology and is co-chair of the nonclinical section of the Drug Information Association.

Dr. Kenneth Hastings, sanofi-aventis, USA
Dr Hastings was Associate Director for Pharmacology/Toxicology in the Office of New Drugs, US Food and Drug Administration, from 2003 to 2007. He currently is Associate Vice President for Regulatory Policy at sanofi-aventis. He has served in several professional societies, including the American Board of Toxicology (currently President), the American College of Toxicology (currently President-Elect), the Society of Toxicology (Past President of the Immunotoxicology Specialty Section), and as Co-Chair of the Nonclinical Special Interest Committee of the Drug Information Association.

Table of Contents

Part I: International Regulations and Nonclinical Studies for Pharmaceuticals

1 Introduction to the development of drugs



4 Latin America: MERCOSUR Countries

5 Canada


7 Africa

8 China

9 Japan

10 India

11 Australia

Part II: Toxicology Studies Supporting Clinical Development

12 Chronic Repeat Dose Testing

13 Carcinogenicity

14 Genotoxicity

15  Developmental and Reproductive Toxicology

16 Juvenile Testing and Pediatric Claim

17 Immunotoxicology

18 Biologics

19 Vaccines

20  Phototoxicity and Photocarcinogenicity

21 Degradants, Impurities Excipients and Metabolites

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