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Add to basketCondition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Autor/Autorin: Shabir GhulamDr 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, CChe.
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Add to basketTaschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - 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.
Published by LAP LAMBERT Academic Publishing, 2012
ISBN 10: 3659123528 ISBN 13: 9783659123528
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Add to basketKartoniert / Broschiert. Condition: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Autor/Autorin: Shabir Ghulam A.Dr Ghulam Shabir gained his PhD from the University of Sunderland. He worked for top pharmaceutical industries in leadership roles for over 25 years and simultaneously served as visiting professor for several universi.
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Add to basketTaschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - The coherent body of research described in this book is concerned with new HPLC 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 and LC-MS. 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.