Statistic in pharmaceutical analytical methods validation.

      Аннотация: Validation of the analytical methods which are used during drug development and drug manufacturing is required to demonstrate that the methods are fit for their intende purpose.Additionally,the pharmaceutical industry around the world is subject to extensive regulations due to the nature of its products.The definitive reference for this topic is the guideline produced by the International Conference on Harmonisation of Technical Requirementsfor Registration of Pharmaceuticals for Human Use (ICH), Q2(R1) ‘Validation of Analytical Procedures: Text and Methodology’. Sections of the guideline have been reproduced in this book with the kind permission of the ICH Secretariat. All ICH guidelines are available via the website, www.ich.org, and thus the validation guideline may be easily checked for revisions.

Ключевые слова: accuracy, Analytical Method development and Validation, HPLC, Linearity, precision, robustness, Statistics, uv spectrophotometric, Limit of detection (LOD) and limit of quantification (LOQ)