Specification of Drug Substances and Products: Development and Validation of Analytical Methods - Couverture rigide

Couverture rigide

ISBN 10 : 0080983502 ISBN 13 : 9780080983509

Editeur : Elsevier / The Lancet, 2013

Synopsis

Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them.

A propos du livre

À propos des auteurs

Dr. Christopher Riley is the President of Riley and Rabel Consulting Services. He received a bachelor's degree in Pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, UK. He taught Pharmaceutical Chemistry, at the Universities of Florida (1983-6) and the University of Kansas (1986-94), and was a Vice President at DuPont Merck (1994-2001) and ALZA (a division of J&J) (2001-7). He has coauthored more than 140 book chapters and papers in peer-reviewed journals, as well as 5 books. He has extensive experience in CMC regulatory affairs and the development of all types of dosage forms.

Former Director of Business Development at Acceleration Laboratory Services, Incorporated. He has previously held scientific and senior management positions at The Upjohn Company, Marion Laboratories, Marion Merrell Dow, Hoechst Marion Roussel, Quintiles, Eli Lilly, Beckloff Associates, and PPD. He currently serves on a Small Molecule USP Expert Committee.

Détails de l'édition

• Éditeur: Elsevier / The Lancet
• Date d'édition: 2013
• Langue: anglais
• ISBN 10: 0080983502
• ISBN 13: 9780080983509
• Reliure: Relié
• Numéro d'édition: 1
• Nombre de pages: 390
• Éditeur: Riley PhD Christopher M., Rosanske Thomas W.
• Coordonnées du fabricant: non disponible
• Personne responsable: Barbara Criscuolo; b.criscuolo@lswr.it; ; Via Spadolini, 7; Milano; 20141; Italie