Download e-book for iPad: Nonclinical Safety Assessment: A Guide to International by William J. Brock,Kenneth L. Hastings,Kathy M. McGown

By William J. Brock,Kenneth L. Hastings,Kathy M. McGown

Bringing a brand new drug to marketplace is a expensive time-consuming technique. elevated local and foreign law over the past 20 years, whereas valuable, has basically served to enlarge those charges. in accordance with this escalation, developmental options have shifted in the direction of a extra worldwide technique. for you to create the main least expensive and secure techniques, it's serious for these bringing medicinal drugs to marketplace to appreciate either the globally accredited laws and the neighborhood diversifications. Nonclinical safeguard overview: A advisor to overseas Pharmaceutical Regulations presents a realistic description of nonclinical drug improvement laws and necessities within the significant marketplace areas.

It includes:

  • ICH – the overseas convention on Harmonisation of Technical necessities for Registration of prescription drugs for Human Use
  • National rules, together with US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia
  • Repeated dose toxicity studies
  • Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology
  • Biotechnology-derived pharmaceuticals
  • Vaccine development
  • Phototoxicity and photocarcinogenicity
  • Degradants, impurities, excipients and metabolites

Primarily meant for these pros actively keen on the nonclinical and scientific improvement of a pharmaceutical product, together with toxicologists, pharmacologists, clinicians and venture managers, this publication offers a roadmap for winning new drug approval and marketing.

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Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations by William J. Brock,Kenneth L. Hastings,Kathy M. McGown

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