Principles of Good Clinical Practice - Couverture souple

 
9780853697909: Principles of Good Clinical Practice
Couverture souple
ISBN 10 : 0853697906 ISBN 13 : 9780853697909
Editeur : Pharmaceutical Press, 2010

Synopsis

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.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Revue de presse

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

Présentation de l'éditeur

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.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
Pharmaceutical Press
Date d'édition
2010
Langue
anglais
ISBN 10 
0853697906
ISBN 13 
9780853697909
Reliure
Broché
Numéro d'édition
1
Nombre de pages
272
Éditeur
McGraw Michael J., George Adam N., Shearn Shawn P., Hall Rigel L., Haws Jr. Thomas F.
Coordonnées du fabricant
non disponible
Personne responsable
non disponible