Study Director Nonclinical - Brock; Fu; Mounho
140,99 €
inkl. MwSt.
Versandkostenfrei*
Versandfertig in über 4 Wochen
payback
70 °P sammeln
  • Gebundenes Buch

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…mehr

Andere Kunden interessierten sich auch für
Produktbeschreibung
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 roles and responsibilities of a Study Director to manage an effective study * Covers regulatory and scientific concepts, including multi-site testing and Good Laboratory Practice (GLP) regulations, compliance with testing 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 It begins with the basic concepts of regulatory definitions, international testing guidelines and Good Laboratory Practice (GLP) regulations, facility management, and regulatory inspections. The second part then deals with the conduct of a nonclinical study, critical to a successful outcome, and one of the more challenging tasks for a Study Director: developing a protocol. The third section describes specialized studies and the final chapter compiles the case studies and lessons learned from those that have been active participants in nonclinical studies for many years. With such comprehensive coverage across the spectrum of nonclinical testing, the book is applicable to several industries including pharmaceutical, safety science, biotechnology, and regulatory science.
Autorenporträt
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.