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Study Director Nonclinical

Name: Study Director Nonclinical
Brand: Wiley
SKU: 9781118370391
Price: 127.99 USD
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Contributors:

William J. Brock (Editor), Barbara Mounho (), Lijie Fu ()

Publisher:

Wiley

Binding:

Hardcover

Book Category:

Science, Medical

Book Subcategory:

Chemistry, Diagnosis

Book Topic:

Industrial & Technical, Toxicology

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The product is eligible for a complimentary return within 30 days from the date of purchase. Furthermore, individual items are shipped within 24 hours of receiving the order.

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Specifications +

Release Date:

2014-06-03

ISBN 13:

9781118370391

Weight:

3.35 lbs

Size:

11.00 x 8.80 x 1.40 inches

Pages:

560

Mint Condition +

product description

Description

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

About the Author

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.

Study Director Nonclinical

Description

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