HPLC Method Development and Validation in Pharmaceutical Analysis: Handbook for Analytical Scientists - Couverture souple

Shabir, Ghulam

 
9783659321207: HPLC Method Development and Validation in Pharmaceutical Analysis: Handbook for Analytical Scientists
Couverture souple
ISBN 10 : 3659321206 ISBN 13 : 9783659321207
Editeur : LAP LAMBERT Academic Publishing, 2013

Synopsis

This handbook is concerned with new chromatographic method development and validation using novel systematic approaches for pharmaceutical compounds. The first stage of the research was to study how method development and validation are typically carried out at present and to formulate this into a simple step-by-step approach. Such a template and protocol was not only used as the foundation of this research programme but could also serve as a simple systematic guide for other practitioners in the pharmaceutical industry. Furthermore, it was recognised that this protocol should satisfy the requirements of the major regulatory agencies. The second stage of this research involved evaluation and application of the above validation approach to new methods that were developed for a diverse range of analytes using HPLC, LC-MS and GC. In essence, the critical review of the requirements for method validation for various agencies and the subsequent preparation of single guidelines on how to go about method validation have had a significant impact on analytical practitioners worldwide.

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

Présentation de l'éditeur

This handbook is concerned with new chromatographic method development and validation using novel systematic approaches for pharmaceutical compounds. The first stage of the research was to study how method development and validation are typically carried out at present and to formulate this into a simple step-by-step approach. Such a template and protocol was not only used as the foundation of this research programme but could also serve as a simple systematic guide for other practitioners in the pharmaceutical industry. Furthermore, it was recognised that this protocol should satisfy the requirements of the major regulatory agencies. The second stage of this research involved evaluation and application of the above validation approach to new methods that were developed for a diverse range of analytes using HPLC, LC-MS and GC. In essence, the critical review of the requirements for method validation for various agencies and the subsequent preparation of single guidelines on how to go about method validation have had a significant impact on analytical practitioners worldwide.

Biographie de l'auteur

Dr Ghulam Shabir, PhD from University of Sunderland. He worked for top pharmaceutical industries in leadership roles for 27 years and simultaneously served as visiting Professor and Fellow for several Universities including OXFORD Brookes. He is the author of 65 peer-reviewed papers, 3 books and has received many top cited author status awards.

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

Éditeur
LAP LAMBERT Academic Publishing
Date d'édition
2013
Langue
anglais
ISBN 10 
3659321206
ISBN 13 
9783659321207
Reliure
Broché
Nombre de pages
492
Coordonnées du fabricant
non disponible
Personne responsable
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