Making science work

Target groups

Scientists working in the pharmaceutical industry in Formulation, Quality Control, Pharmacokinetics and Bioequivalance, and Regulatory Sciences, academic scientists with interest in Oral Biopharmaceutics and scientists working in Regulatory Authorities are invited to learn more about Oral Biopharmaceutics Tools.

Objective

• Assess the opportunities provided by biorelevant performance testing
• Examine case studies using biorelevant dissolution examinations to assess product performance attributes
• Communicate efforts to improve and facilitate the in vivo predictability of biorelevant tests
• Present PBPK modeling approaches for addressing the impact of oral absorption process on plasma levels
• Address strategies for linking quality control dissolution methods with biorelevant in vitro performance testing
• Discuss quality by design (QbD) applications, Process Analytical Technology (PAT) and physiologically based pharmacokinetic modeling
• Discuss discriminating methods and how to address process changes during the lifecycle of a drug product

Overview of the workshop
Dissolution testing is an important tool from early development to life cycle management of a drug product. With the Quality by Design (QbD) approach critical process parameters, material attributes and quality attributes are identified. Their impact on in-vitro dissolution and bioavailability are assessed.

In early development, biorelevant dissolution/release testing, i. e. the evaluation of luminal behavior 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 utilized to decrease the number of in vivo studies required during the drug development process and to mitigate the risk related to in vivo bioequivalance 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.

There will be a general discussion session at the end of workshop, as well as the opportunity for attendees to ask questions at the conclusion of each presentation.