ZOOM Online: Dissolution and the assessment of bioavailability/bioequivalence – 3.5 hours
An optional half day webinar to follow the 2 day 'Pharmaceutical Dissolution Testing' course will deal with the use of dissolution testing in the assessment of bioequivalence, including biowaivers and in vitro-in vivo correlation. This additional component will also cover approaches for evaluating bioavailability and the conduct of clinical trials to establish bioequivalence. The risks of failing to establish bioequivalence because of poor choice of reference product batch and highly-variable pharmacokinetics are also discussed.
- Bioavailability and bioequivalence"definitions and in vivo evaluation
- In vitro biowaivers
- In vitro-in vivo correlation
Mark Powell - Analytical Services (Dissolution Testing, QbD, HPLC)
Mark is a Fellow of the Royal Society of Chemistry with over thirty years' experience as a senior analytical chemist. He taught pharmaceutical analysis at the Liverpool John Moores University School of Pharmacy and Chemistry from 1997 to 2003 and was also active in research.
In 2003, he joined the newly-formed Quay Pharmaceuticals, a contract research and manufacturing organisation specialising in early-stage drug development, where he was responsible
for analytical development. Since 2010, as Quay"s Scientific Manager, Mark was involved more generally with drug development programmes and also established collaborations with a number of UK universities and instrument manufacturers. His work at Quay has resulted in a number of published papers and presentations at scientific conferences.
In 2013 Mark set up his own consultancy company and has since worked
for clients all over the world on both early-stage and late-stage drug
development projects. He has particular expertise in dissolution method development and chromatography, and is in demand as a trainer in topics ranging from pharmaceutical analysis to data integrity and technical report writing.
This 3.5 hour online course will benefit anyone requiring an intensive introduction to dissolution testing and the associated procedures working in the following areas:
- Regulatory Affairs
- Pharmaceutical Development
- Analytical Development
- Project Management
- Quality Control
- Quality Assurance