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Statistic in pharmaceutical analytical methods validation - Amiya Kumar Ghosh

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2018-01-08
31,01 € 51,68 €

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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 Harm ... Täielik kirjeldus

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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 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.

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Autor Amiya Kumar Ghosh
Kirjastaja LAP LAMBERT Academic Publishing
Väljalaskeaasta 2018
Kaanetüüp Pehme kaanega
EAN 9786202076982
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31,01 € 51,68 €