Statistic in pharmaceutical analytical methods validation
Amiya Kumar Ghosh
Broschiertes Buch

Statistic in pharmaceutical analytical methods validation

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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...