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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.
The 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
Led by Jean-Michel Cardot, course leader for Practical Solutions for Establishing IVIVC and Bioavailability and Bioequivalence.
In 30 minutes, this webinar explores how to optimise IVIVC using your dissolution data.
Topics covered:
Basis of IVIVC
Why IVIVC and dissolution are important
Use in development: interest and limitations
Optimisation of formulation based on IVIVC
Conclusions and Q&A session