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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