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Brock, William

Nonclinical Safety Assessment

A Guide to International Pharmaceutical Regulations

€ 180.95

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.


Taal / Language : English

Inhoudsopgave:
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
Extra informatie: 
Hardback
486 pagina's
Januari 2013
886 gram
250 x 177 x 28 mm
Wiley-Blackwell us

Levertijd: 5 tot 11 werkdagen