OverviewBiorelevant in vitro performance testing of orally administered dosage forms has become an important tool for the assessment of drug product in vivo behaviour.
Biorelevant dissolution/release testing is useful for the evaluation of formulation and food effects on plasma levels and intraluminal dosage form performance after administration of oral drug products.
It has also been 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.
This workshop will discuss data on the luminal environment, its simulation, biorelevant in vitro performance testing methodologies that can be applied during product development, as well as relevant in silico modelling methodologies.
Case studies from industry will describe the application of biorelevant testing methodologies for formulation design, selection and development vs. currently applied procedures in quality control testing.
In addition, presentations from the FDA and National Competent Authorities will cover the use of biorelevant testing in the evaluation of a drug’s performance.
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