Validation of Analytical Methods for Pharmaceutical Analysis (£29.90)
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.