HPLC, LC-MS and GC Method Development and Validation: Guideline for academic and industrial scientists involved in method development and validation - Couverture souple

Shabir, Ghulam

 
9783848489541: HPLC, LC-MS and GC Method Development and Validation: Guideline for academic and industrial scientists involved in method development and validation
Couverture souple
ISBN 10 : 3848489546 ISBN 13 : 9783848489541
Editeur : LAP LAMBERT Academic Publishing, 2012

Synopsis

The coherent body of research described in published work is concerned with new assay method development and validation using novel systematic approaches for pharmaceutical and diagnostic compounds. The first stage of the research was to study how analytical 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 and those new to the field. Furthermore, it was recognised that this protocol should satisfy the requirements of the most strategically important 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 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

The coherent body of research described in published work is concerned with new assay method development and validation using novel systematic approaches for pharmaceutical and diagnostic compounds. The first stage of the research was to study how analytical 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 and those new to the field. Furthermore, it was recognised that this protocol should satisfy the requirements of the most strategically important 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 guidelines on how to go about method validation have had a significant impact on analytical practitioners worldwide.

Biographie de l'auteur

Dr Ghulam Shabir has a PhD in Analytical Chemistry from the University of Sunderland UK. He has worked in QC and QA in pharmaceutical industry and has received technical excellence and academic awards. He is a CSci, CChem and Fellow of the Royal Society of Chemistry, the author of sixty articles and has received 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
2012
Langue
anglais
ISBN 10 
3848489546
ISBN 13 
9783848489541
Reliure
Broché
Nombre de pages
96
Coordonnées du fabricant
non disponible
Personne responsable
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