Dissolution testing of oral dosage forms in context: a review of its physiological relevance
Paul Dickinson, Astra Zeneca

Workshop 1
Selection of media and methods for oral dose forms, with an emphasis on early stage development
James Butler, GSK

Dissolution testing of novel/special dosage forms
Nikoletta Fotaki, University of Bath

Equipment for Dissolution Testing of Non-oral Dosage Forms
Terry Way, Consultant

Introduction
Terry Way, Consultant

Dissolution method development with an emphasis on late stage development
Paul Dickinson, AstraZeneca and David Holt, AstraZeneca

Refreshments

Regulatory Requirements.
How development data relate to Compendial Requirements (Ph.Eur.)
Evangelos Kotzagiorgis , EMA

Lunch

Methods of Analysis
James Mann, MSD        

Refreshments

Dissolution equipment qualification & method validation
Terry Way, Consultant

Review of Day 2 with general discussion/Q&A
All

Introduction
Terry Way, Consultant

Demonstrating in vitro/in vivo relationships (IR & MR dose forms) using “In Vivo Simulators”
James Mann, MSD

Refreshments

Using dissolution testing to demonstrate dose form equivalence
Nikoletta Fotaki, University of Bath

Regulatory Examples of Dissolution Issues in the Assesment of Products
Evangelos Kotzagiogis, EMA

Workshop 3
Biowaivers and SUPAC
Nikoletta Fotaki, University of Bath

Summary of course & immediate feedback
All

Close of meeting