The Role of the Study Director in Nonclinical Studies (ePub)
Pharmaceuticals, Chemicals, Medical Devices, and Pesticides
(Sprache: Englisch)
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...
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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
* 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
Autoren-Porträt
William J. Brock is the Principal of Brock ScientificConsulting, 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.
Bibliographische Angaben
- 2014, 1. Auflage, 560 Seiten, Englisch
- Herausgegeben: William J. Brock, Barbara Mounho, Lijie Fu
- Verlag: John Wiley & Sons
- ISBN-10: 1118874080
- ISBN-13: 9781118874080
- Erscheinungsdatum: 02.05.2014
Abhängig von Bildschirmgröße und eingestellter Schriftgröße kann die Seitenzahl auf Ihrem Lesegerät variieren.
eBook Informationen
- Dateiformat: ePub
- Größe: 14 MB
- Mit Kopierschutz
Sprache:
Englisch
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