🎉   Please check out our new website over at books-etc.com.

Seller
Your price
£49.00
Out of Stock

Principles of Good Clinical Practice

Pharmacy Business Administration

Format: Paperback / softback
Publisher: Pharmaceutical Press, London, United Kingdom
Published: 3rd Aug 2010
Dimensions: w 155mm h 234mm d 17mm
Weight: 428g
ISBN-10: 0853697906
ISBN-13: 9780853697909
Barcode No: 9780853697909
Trade or Institutional customer? Contact us about large order quotes.
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.

New & Used

Seller Information Condition Price
-New
Out of Stock

What Reviewers Are Saying

Submit your review
Newspapers & Magazines
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 *