Conference - Frankfurt, Germany
Dissolution testing is an important tool from early development to life cycle management of a drug product. The implementation of Quality by Design (QbD) principles requires understanding of process parameters, product attributes and their impact on in-vitro dissolution and bioavailability.
In early development, biorelevant dissolution/release testing, i.e. the evaluation of luminal behaviour of drug products in gastrointestinal lumen with in vitro methodologies, is useful for predictions of formulation and food effects on plasma levels. It is also utilised to decrease the number of in vivo studies required during the drug development process and to mitigate the risk related to in vivo bioequivalence studies.
Recent updates and case studies on these subjects will be discussed by scientists working in academia, industry and regulatory agencies from Europe, the US and Japan.
Key sessions and topics include:
Biorelevant Testing and Methodology Tools and Applications
Definitions/background for biorelevant testing
Update of a current relevant EU initiative (orbito project)
Preclinical and clinical applications
PBPK modelling
Quality Control Applications
Quality by Design (QbD) applications; Real Time Release Testing (RTRT)
Discriminating methods and addressing process changes during life cycle of a drug product
Organization: DIA Europe, Middle East & Africa
Joint DIA/FIP Workshop on "Dissolution Testing"
Mon, Feb 22, 2016 - Tue, Feb 23, 2016
NH Hotel Frankfurt Niederrad
Lyoner Str. 5, Frankfurt, Germany
