Principles of Good Clinical PracticeBy: Michael J. McGraw, Adam N. George, Shawn P. Shearn
Stock status: Available to Order (Stock Due)
(No VAT Payable)
Details: Paperback, 272 pages.
Publication date: 30/07/2010
Publisher: Pharmaceutical Press
Publication Status: Active
Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
Good clinical practice guidelines providing an international quality standard for the regulation of clinical trials. This title is one of the "RPS Pharmacy Business Administration Series" which aims at covering all business aspects relating to pharmacy practice. Good Clinical Practice is an international quality standard for the regulation of clinical trials. GCP guidelines include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights. This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials. It also includes historical development, trends, review of current system and future development.
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 "...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