Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations
by Brock, William J.; Hastings, Kenneth L.; McGown, Kathy M.Edition: 1st
Format: Hardcover
Pub. Date: 2013-04-29
Publisher(s): Wiley
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Summary
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
2 ICH
3 USFDA
4 Latin America: MERCOSUR Countries
5 Canada
6 EMEA
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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