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STABILITY-INDICATING ASSAY 1987 guideline‘quantitative analytical methods that are based on the characteristic structural, chemical or biological properties of each actie…

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Regulatory Requirements with Relevance for Quality of API Beijing, March 2010 Jean-Louis ROBERT National Health Laboratory L – 1011 LUXEMBOURG CHMP co-opted member Chair…

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Common Technical Document (CTD) Dr Pravina ICRI What is the CTD? The CTD refers to an application format and not to an application type • The CTD is a prescribed organization…

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Slide 1Large trials: key factors for obtaining clear answers Rory Collins BHF Professor of Medicine & Epidemiology Clinical Trial Service Unit & Epidemiological Studies…

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1. BEST GUIDANCE AND PRACTICES FORSTRESS STABILITY TESTINGRAHUL KUMAR YADAVPA/2010/08 2. AGENDA………..1)INTODUCTION2)IMPORTANCE3)EXPERIMENTAL DEGISNING4)ISSUES5)DIVERSITY…

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Slide 1 ETHICAL REVIEW 20060915 1/46 JHGJ/gh THE CHANGING NATURE OF ETHICAL REVIEW Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph., Clinical Pharmacologist University…