Analytical Method Validation Training Book
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This book is based on our popular training course ‘Validation of Analytical Methods for Pharmaceutical Analysis’, which deals with applying the available regulatory guidelines on method validation, such as ICH and FDA, to methods used for the chemical analysis of pharmaceuticals.
Shipping information
Postage and packing is FREE to UK and Ireland addresses and is very reasonably priced for other locations at only GBP £3.50 for Europe and GBP £5.50 for the rest of the world. Shipping times depend on your location but are typically less than 14 days from the date of the order.
Preview
We understand the difficulty of buying a book online. You cannot just pick it up and leaf through the pages to help you decide if it is the right book for you. Therefore a preview made up of a selection of the pages in this book is provided to give a flavour of the content and style. You may also wish to visit the MTS training resources area where there are a selection of useful articles written by the author, Oona McPolin.
Other products available from MTS include a book on HPLC and online, pre-prepared training courses for in-house use. Additionally, our services include training courses on HPLC and method validation and training consultancy services such as training needs analysis (TNA).
Validation of Analytical Methods for Pharmaceutical Analysis
Cost: GBP £29.90
Author: Oona McPolin
ISBN: 978-0-9561528-1-7
Format: Paperback, 210 x 300mm (A4), 152 pages
Publisher: Mourne Training Services
Synopsis:
Methods which are used for the analysis of pharmaceuticals generate critical data and it is essential that the quality of this data is assured. Validation is required to demonstrate that these analytical methods are fit for their intended purpose. Validation data is also required by legislation, it is included in submissions to regulatory authorities all around the world for clinical trial and marketing applications. This book provides guidance on how to carry out a validation study for analytical methods.
Key features include:
Full review of the available regulatory guidelines on validation and in particular, those from the International Conference on Harmonisation (ICH). Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat.
Thorough discussion of each of the validation characteristics: Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability; plus practical tips on how they may be studied.
What to include in a validation protocol, with advice on the experimental procedure to follow and selection of appropriate acceptance criteria.
How to interpret and calculate the results of a validation study, including the use of suitable statistical calculations.
A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.
Contact us for a quote if you want to buy more than one book
“A nicely written handbook on how to perform validation of methods used in pharmaceutical analysis.” – Chemistry World, May 2010
