Principles of Good Clinical Practice (Pharmacy Business Administration)

Michael J. McGraw (ed)

ISBN 10: 0853697906 / ISBN 13: 9780853697909

Published by Pharmaceutical Press, 2010

About this Item

This is an ex-library book and may have the usual library/used-book markings inside.This book has soft covers. In fair condition, suitable as a study copy. Please note the Image in this listing is a stock photo and may not match the covers of the actual item,500grams, ISBN:9780853697909.

Seller Inventory # 9796092

Bibliographic Details

• Title: Principles of Good Clinical Practice (Pharmacy Business Administration)
• Publisher: Pharmaceutical Press
• Publication Date: 2010
• Language: English
• ISBN 10: 0853697906
• ISBN 13: 9780853697909
• Binding: Soft cover
• Condition: Fair
• Weight: 500 grams
• Seller catalogs:
  • Medicine

About this title

Synopsis

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.

From the Back Cover

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, ContractResearch Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries.Michael J McGraw is Adjunct Assistant Professor at Temple University School of Pharmacy and Senior Manager of Regulatory Affairs, Teva Neuroscience, USA.