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.
General
Imprint: |
Lap Lambert Academic Publishing
|
Country of origin: |
Germany |
Release date: |
May 2012 |
First published: |
June 2012 |
Authors: |
Ghulam A. Shabir
|
Dimensions: |
229 x 152 x 18mm (L x W x T) |
Format: |
Paperback - Trade
|
Pages: |
308 |
ISBN-13: |
978-3-659-12352-8 |
Categories: |
Books >
Science & Mathematics >
Chemistry >
General
Promotions
|
LSN: |
3-659-12352-8 |
Barcode: |
9783659123528 |
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