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Nonclinical Safety Assessment – A Guide to International Pharmaceutical Regulations de WJ Brock

Nonclinical Safety Assessment – A Guide to International Pharmaceutical Regulations

Autor WJ Brock
en Limba Engleză Hardback – 11 apr 2013
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.
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Specificații

ISBN-13: 9780470745915
ISBN-10: 0470745916
Pagini: 486
Dimensiuni: 177 x 250 x 28 mm
Greutate: 0.86 kg
Editura: Wiley
Locul publicării:Chichester, United Kingdom

Public țintă

  • Regulatory Affairs professional in pharmaceutical companies, contract research organizations, or working as consultants
  • Those in a regulatory capacity where there is a need to define the requirements of preclinical testing in other regions. 
  • Toxicologists in pharmaceutical companies involved in study design
  • Students enrolled on toxicology and pharmaceutical sciences programs, and pharmaceutical employees undergoing continuing professional development

Cuprins

Notă biografică

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.

Descriere

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.