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WEBINAR: Specifications for Small Molecule Drug Products 8 лет назад


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WEBINAR: Specifications for Small Molecule Drug Products

Led by Dr Mark Powell, a Fellow of the Royal Society of Chemistry (RSC) with over 25 years’ experience as a senior analytical chemist. In 2013, Mark set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry. This webinar will cover: • Regulatory guidance (ICH, FDA, EMA) • Tests appropriate to different dosage forms • Dissolution specifications for immediate-release, modified-release and extended-release drug products • Dissolution specifications in the context of the biopharmaceutical classification system • Control of polymorphism, enantiomeric purity, drug-related impurities and microbiological contamination • Specifications for combination drug products • The role of specifications in maximizing drug product stability

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