000			01611nam a2200181Ia 4500
008			140223b2005 xxu||||| |||| 00| 0 eng d
020			_a9783527312559 _c0.00
082			_a615.1901 _bMET
245			_aMethod Validation in Pharmaceutical Analysis
260			_aWeinheim _bWiley-VCH Verlag Gmbh _c2005
300			_a403p
500			_aAdopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities. Show More Show Less
600			_aPharmaceutical Analysis _9105057
700			_aErmer, Joachim _eEditor _9105058
700			_aMiller, John H. McB _eEditor _9105059
942			_2ddc _cLB
995			_aPharmacy Reference _eP0002177 _j615.1901 _yP0002177
999			_c15830 _d15830