Seda’s Paul Dickinson took the stage at the PBBM (Physiologically Based Pharmacokinetics Modelling) Conference 2024, hosted by the MHRA and APS. The event was a fantastic opportunity for regulatory agencies, innovator and generic drug companies, consultants, academia, commercial software providers, and others in the field of oral drug product modelling and simulation to come together and explore the latest advancements in PBBM while influencing the future pathway for regulatory use.

About Paul’s Talk:
Paul’s presentation was titled: Clinically Relevant Dissolution Specifications: Implications for Use in the Post-Marketing Setting & Tension with f2 Similarity Testing. We are proud to see Paul, one of the originators of the “safe space” concept, contributing to this vital conversation. His influential paper on the Clinical Relevance of Dissolution Testing in Quality by Design has set a benchmark in our field.

Access the slides from Paul’s presentation can be found here.

For me the big ticket CMC items to get ticked off as soon as possible for any NDA/MAA submission are:
1. Dissolution method and specification
2. Registered Staring Material
because if these are not accepted the whole CMC package is at risk and the ‘right’ answer is open to interpretation. PPBM can support the Sponsors justification of Item 1 and so maybe of critical value in regulatory discussions and so it is good for drug developers to have awareness of the strengths and limitations of PPBM is supporting approval and post-approval changes. As an aside in any submission demonstration of good control and understanding of API solid-state form /polymorph is also an important factor sometimes overlooked in dossiers. – Paul Dickinson, Chief Scientist

This was an inspiring event that will shape the future of biopharmaceutics!

Read more about Seda’s pk modelling services or contact us to speak to one of our expert team.