'Ich guidelines' diaporamas de présentation

DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES

DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES. BY M.PAUL RICHARDS. INTRODUCTION. ANALYTICAL PROCEDURES. RESIDUAL SOLVENTS ICH GUIDELINES CO - SPONSORS OF ICH. WHO GOVERN ICH AREAS OF ICH GUIDE LINES. THE STATUS OF ICH GUIDE LINES. ANALYTICAL PROCEDURES.

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Research Project Design Study Design

Research Project Design Study Design. Part 2. Study Design. Observational studies Descriptive Analytical Intervention studies Medical tests Exposure / treatment. 1.Were groups compared?. Yes. No. Analytical. Descriptive. 2.How many in study?. 3. Treated/exposed?. No. Yes. One.

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On ICH

On ICH. Feb. 13, 2013 Toshi Tominaga Ph. D. Food and Drug Evaluation Center, Osaka City Univ. Hospital International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical Product Development: An Institute of Medicine Workshop.

357 views • 14 slides

FusionChrom ?

FusionChrom ?. Analytical Method Development And Method Validation. Automated Experimentation. FusionChrom. Chemometric platform for analytical method validation. Auto-control of instrument parameters, external solvent selection valves, and column switching.

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Japanese Safety Pharmacology Society

Japanese Safety Pharmacology Society. Meeting of Promoters September 5 th , 2009 Keiji Yamamoto, DVM, MBA, PhD. K. Yamamoto (Takeda Pharmaceutical) M. Tabo (Chugai) T. Kitayama (Kyowahakko-Kirin) H. Tashibu (Dainippon-Sumitomo) C, Kasai (Astellas) S. Toyoshima (Ootsuka)

404 views • 8 slides