Dissolution Testing and Biowaivers

Date to be announced

Price available after dates are announced

TRAINING TIMES

TBDVienna
TBDLondon
TBDNew York
TBDLos Angeles

LEARNING OBJECTIVES

Understand the science of dissolution testing

Appreciate the uses and potential problems associated with compendial dissolution apparatus

Be able to adopt a logical approach to the development of an appropriate dissolution method for both highly soluble and poorly soluble drugs

Gain the ability to troubleshoot dissolution results logically

Be able to design an appropriate dissolution validation study

Understand the uses of in vitro dissolution data to support a waiver of in vivo clinical studies (biowaiver)

KEY TOPICS

The importance of dissolution testing – drug safety and efficacy

Factors affecting solubility and dissolution rate (the Noyes–Whitney model)

Dissolution testing apparatus for solid oral dosage forms – characteristics and uses

TRAINER

Dr Mark Powell

Mark Powell Scientific Limited, UK, Director

Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in several companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers. In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, and stability/stress studies.

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Video Invitation

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