Principles of Good Clinical Practice (Pharmacy Business Administration) - Softcover

Michael J. McGraw; Adam N. George; Shawn P. Shearn; Rigel L. Hall; Thomas F. Haws

9780853697909: Principles of Good Clinical Practice (Pharmacy Business Administration)

Softcover

ISBN 10: 0853697906 ISBN 13: 9780853697909

Publisher: Pharmaceutical Press, 2010

Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights. Principles of Good Clinical Practice describes the ethical principles and regulatory requirements that influence the current and future conduct of clinical research. As well as providing essential information on clinical trial design and pharmacovigilance, coverage also includes: informed consent; investigator and sponsor responsibilities; site monitoring; institutional review boards and independent ethics committees; clinical trial registration and reporting; quality assurance; future implications for good clinical practices. This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials, as well as providing a historical perspective of the clinical research landscape. Principles of Good Clinical Practice will be a definitive text for Clinical Development personnel at pharmaceutical companies, Contract Research Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries.

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Review:

Selected for "The First Clinical Research Bookshelf" - Essential reading for clinical research professionals. " a readable introductory summary of Good Clinical Practice (GCP) for pharmaceutical studies based on U.S. regulations and ICH E6 guidelines, which FDA has adopted as guidance...the book strikes a good balance between too much and too little detail" Norman M. Goldfarb, Journal of Clinical Research Best Practices Vol. 7(7), July 2011 (Norman M. Goldfarb Journal of Clinical Research Best Practices)

"...details requirements and discusses ethics surrounding clinical investigational trials. This is a worthy topic and relevant to pharmacy practice...an appropriate book for someone new to research, interested in doing research, or in an academic environment." Barbara Lane Giacomelli, PharmD, MBA, BS, FASHP (Shore Memorial Hospital) Doody's Notes, November 2010 (Barbara Lane Giacomelli Doody's Notes)

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