The Role of the Study Director in Nonclinical Studies: Pharmaceuticals, Chemicals, Medical Devices, and...

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William J. Brock (Brock Scientific Consulting) Barbara Mounho

The Role of the Study Director in Nonclinical Studies

Pharmaceuticals, Chemicals, Medical Devices, and Pesticides

William J. Brock (Brock Scientific Consulting), Barbara Mounho, Lijie Fu

$230.95

Hardback

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English

John Wiley & Sons Inc
23 May 2014

Scientific standards; Scientific equipment, experiments & techniques

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book:

Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Edited by: William J. Brock (Brock Scientific Consulting)
Associate editor: Barbara Mounho, Lijie Fu
Imprint: John Wiley & Sons Inc
Country of Publication: United States
Dimensions: Height: 287mm, Width: 226mm, Spine: 38mm
Weight: 1.538kg
ISBN: 9781118370391
ISBN 10: 1118370392
Pages: 560
Publication Date: 23 May 2014
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Active

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.