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Dissolution Testing

27 - 28 November 2017

Radisson Blu Edwardian Grafton, London

Agenda

Learn the critical steps to accurately measure the performance of your drug product

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Dissolution testing poses a major challenge to the pharmaceutical, biotech and generics industries both in terms of method development and regulatory compliance.

This two-day interactive training course will explain the history, benefits, importance and role of dissolution testing in drug development today. Using practical examples and case studies throughout, delegates will gain a thorough understanding of setting and establishing specifications for optimum dissolution testing.

Clarify global regulatory requirements
Assess new scientific developments and trends
Design optimum method development strategies
Identify the factors affecting dissolution
Drive product performance and quality control
Study design considerations for IVIVC Studies

Gain a practical introduction to the intricacies of dissolution testing with an emphasis on problems and problem solving
Select optimum test conditions and method development
Ensure your test methods are properly validated
Enhance the dissolution rate and bioavailability of your compound
Clarify the theory and regulatory aspects involved in developing IVIVC models

Eric Beyssac

Eric Beyssac received a Master’s in Pharmacy and a Ph.D. degree in Pharmaceutical Technology, from the Faculty of Pharmacy, Clermont-Ferrand (France), where he is currently a Professor. He was an invited Professor at the Faculty of Pharmacy of Université Lavalin Québec from 2000 to 2002 and is still Associate Professor at this university. He is currently co-director of the research group CIDAM "Conception, Ingénierie et Développement de l'Alimentet du Medicament" (Conception, Engineering and Development of Food and Drugs). He has authored more than 35 publications in various national and international journals. His research interests include the following: In vitro in vivo correlations, sustained release drug dosage form development, and in vitro dissolution.

This course is designed for professionals working in the following areas:

Regulatory Affairs
Pharmaceutical Development
Analytical Development
Project Management
Quality Control
Quality Assurance

Specifications for Small Molecule Drug Products Webinar

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

IVIVC - A Way to Speed up Development Using Dissolution as a Surrogate Tool.

Led by Jean-Michel Cardot, course leader for Practical Solutions for Establishing IVIVC and Bioavailability and Bioequivalence.
In 30 minutes, this webinar explores hot 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

Learn the critical steps to accurately measure the performance of your drug product

Eric Beyssac

Specifications for Small Molecule Drug Products Webinar

IVIVC - A Way to Speed up Development Using Dissolution as a Surrogate Tool.

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