Experience meets meets
Wednesday 11 October 2023

Bioequivalence: New trends and recent discussions

The future is harmonization: ICH M13 paves the path for a globally uniform approach – a path with many controversial discussions but also innovative ideas.

With our workshop we want to show that the topic is still exciting. We will introduce you to the current state of the international discussions of harmonisation, focus on some burning open issues and we will show future approaches that have a chance to contribute to international modern trends.

Good and sustainable bioequivalence studies thrive on a design that covers current and future regulatory requirements and on a quality approach that ensures regulatory acceptance. We have put together presentations for you that will still provide new insights even for professionals and at the same time give a good overview of the current status.

Get involved with our event: Our history at SocraTec R&D and SocraMetrics is rooted in bioequivalence! Thus, it is more than plausible to start our Anniversary Workshop Series with this topic, even though today our spectrum is of course much broader.

We look forward to welcoming you to join us.

Schedule

09:00
Morning Reception
09:45
Welcome and introduction
10:00-10:30

ICH M13: Old wine in new bottles - or cornerstone for advanced BE regulations?

Summary of the outcome of recent discussions between members of the drafting group, industry and academia
Henning Blume
Frankfurt Foundation Quality of Medicines
Germany
Henning Blume
10:30-10:40
Discussion
10:40-11:10

ICH M13A: Testing for multi-group and multi-center – effects in BE trials: Statistical considerations and consequences for interpretation

Probability of group-by-treatment interaction based on real world data and simulations: Why »statistically significant« differs from »relevant«
Helmut Schütz
BEBAC Consultancy Services for Bioequivalence & Bioavailability
Austria
11:10-11:40
Discussion and Coffee Break
11:40-12:10

ICH M13A: Endogenous substances and the heterogeneity of physiological baselines – what does this mean for study design and evaluation?

Practical applications of different types of baseline corrections: examples for »time-averaged« versus »time-matched« baseline; Implications for food restrictions and subject selection in BE trials
Barbara Schug
SocraTec R&D GmbH
Germany
12:10-12:20
Discussion
12:20-12:50

ICH M13C: Narrow Therapeutic Index Drugs – ideas for alternative strategies

Elaboration of potential future BE approaches which allow reduction of sample size considering intraindividual variability: A risk-based approach
Paulo Paixao
Infarmed
Portugal
12:50-13:00
Discussion
13:00-14:00
Lunch Break
14:00-14:30

The future: Can PopPK modelling and simulation support generic development?

How PopPK methods based on earlier BE trials, absorption models and established drug specific PK models may support waiver of additional trials - a tailor-made example illustrating realistic approaches
Robin Michelet
qPharmetra / Freie Universität Berlin
Germany
14:30-14:40
Discussion
14:40-15:10

Manipulation of BE trial outcomes: A potential serious risk to public health

Recent cases in the public domain and the big question 'WHY?' - defining 'overlapping profiles' and why they may be un-detectable on source - options for Sponsors when a trial shows patterns of manipulation
Anders Fuglsang
Fuglsang Pharma
Denmark
15:10-15:30
Discussion and Closing Remarks
15:30
Afternoon Reception

Registration

Registration is closed.

Event Venue

Airport Club Frankfurt GmbH
Frankfurt Airport Center I
Hugo-Eckener-Ring
60549 Frankfurt am Main