The Role of the Study Director in Nonclinical Studies – Pharmaceuticals, Chemicals, Medical Devices and Pesticides
John Wiley & Sons Inc (Hersteller)
978-1-118-87392-2 (ISBN)
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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
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.
Erscheint lt. Verlag | 9.5.2014 |
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Verlagsort | New York |
Sprache | englisch |
Maße | 150 x 250 mm |
Gewicht | 666 g |
Themenwelt | Studium ► 2. Studienabschnitt (Klinik) ► Anamnese / Körperliche Untersuchung |
Naturwissenschaften ► Biologie ► Biochemie | |
Naturwissenschaften ► Chemie ► Technische Chemie | |
Technik | |
ISBN-10 | 1-118-87392-0 / 1118873920 |
ISBN-13 | 978-1-118-87392-2 / 9781118873922 |
Zustand | Neuware |
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