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Lijie (Mithrsg.) Fu

The Role of the Study Director in Nonclinical Studies

Pharmaceuticals, Chemicals, Medical Devices, and Pesticides

Ebook (PDF Format)

Invaluable guidance to manage nonclinical safety studies This book is a practical reference aiding Study Directors in the design, execution, and reporting of nonclinical studies. Managing the idiosyncrasies inherent in a nonclinical study represents a significant challenge that can only be learned from doing. The editors and authors provide such valuable lessons learned and case studies from their own extensive experience to guide readers. A single-source reference with a broad and holistic overview of nonclinical studies, this book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the ro… Mehr

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Produktdetails


Weitere Autoren: Mounho, Barbara (Mithrsg.) / Brock, William J. (Hrsg.)
  • ISBN: 978-1-118-87390-8
  • EAN: 9781118873908
  • Produktnummer: 16382834
  • Verlag: Wiley
  • Sprache: Englisch
  • Erscheinungsjahr: 2014
  • Seitenangabe: 560 S.
  • Plattform: PDF
  • Masse: 18'812 KB

Über den Autor


William J. Brock is the Principal of Brock Scientific Consulting, a Diplomate of ABT and a Fellow of ATS. Dr. Brock has over 30 years of experience with conducting nonclinical studies including genotoxicity, safety pharmacology, developmental and reproductive toxicology, carcinogenicity studies, etc. Barbara Mounho is a Biopharmaceutical Practice Leader at ToxStrategies, Inc., a Diplomate of ABT and a Fellow of ATS. Dr. Mounho has >15 years of experience in the nonclinical safety evaluation of therapeutic biological products. Lijie Fu is the Senior Director and Regulatory Advisor at SNBL. He is a Fellow of ATS with over 30 years' experience in toxicology, holding positions in non-clinical CROs in the US and China. Dr. Fu was retained by WHO as an expert to on Safety Evaluation and GLP Regulations.

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