One Health Initiative Webinar Series: Part 3

One Health -- Use of in silico models to promote an understanding drug pharmacokinetics and pharmacokinetic/pharmacodynamics relationships across human and veterinary populations.

Broadcast Date: Thursday, September 1st | 11:00 a.m. - 12:00 p.m.

Click here to view the recording!

Consistent with the One Health Initiative, it is necessary to achieve an understanding of the population variability and interspecies differences that will enable the development of a worldwide strategy for meeting the health care needs of the human or veterinary patient. The third and final lecture in this series will describe the use of physiologically based pharmacokinetic (PBPK) models to achieve insights into the variation in dose-exposure relationships that can occur when a therapeutic is administered across a diverse patient population. The tremendous value of these models is evidenced by the recent draft EMA guidance where the PBPK simulation output, when derived from properly validated models, can have high regulatory impact (being incorporated into the Summary of Products Characteristics). However, it is essential that the predictive capability of these models be fully understood and validated.

With this in mind, Dr. Rostami-Hodjegan will discuss how one can integrate results from in vitro studies, including those with whole cells, tissue samples and solid dosage forms, to assess the metabolism, transport or dissolution/solubility using the Simcyp family of software as the platform for showcasing these examples. Combined with systems data describing the physiological attributes (and variability in these attributes) for the human or animal populations, these PBPK models can be invaluable for understanding and developing targeted dose-exposure-response relationships and for appreciating the variability in that relationship that can exist across the population of potential patients.

Who should attend this webinar:

Individuals involved with the development and use of therapeutic products from the perspective of biopharmaceutics, pharmacokinetics, dose-exposure-response relationships, and interspecies extrapolations (including researchers from academia, industry, and government); physicians; veterinarians; students (human or veterinary medicine, university); environmental scientists. The importance of this topic is showcased by EMA’s recent publication of the first PBPK modelling guidance titled “Guideline on the Qualification and Reporting of Physiologically Based Pharmacokinetic (PBPK) Modelling and Simulation” which covers the application of these models across a range of purposes such as its use in lieu of clinical data (e.g., non-studied dosing scenarios and drug-drug interactions) to its use in dose selection and study optimization.

What attendees will take away:

  • The PBPK/IVIVE (mechanistic) models are distinctly different from the classical pharmaco-statistical compartmental analysis of the data. The concept requires collaboration between the field scientists (formulation, biologists, chemist, physicist) and modelers to make realistic picture of the status of knowledge through the model.
  • These models require detailed information on the system to which the drug is applied to, but this enables them to have higher predictive power for population of individuals who might not conform to the term “average” particularly when these are not studies prior to authorization of the use and there is void of information in the drug level.

About the Speaker

Prof. Amin Rostami-Hodjegan, University of Manchester, Manchester, United Kingdom
Amin is a Professor of Systems Pharmacology at the Centre for Applied Pharmacokinetic Research (CAPKR) in the Manchester Pharmacy School at the University of Manchester. He has an active program of training PhD students in CAPKR in Systems Pharmacology and Pharmacokinetics and numerous students have graduated under his supervision from the University of Sheffield, where he was a Professor of Systems Pharmacology before joining the University of Manchester in 2009. He has authored about 200 peer reviewed publications. A recognition of the outstanding contributions of his research efforts is evidenced by the over 8000 citations of his published documents, which will provide the basis for his upcoming lecture. Amin is also the Senior Vice President of Research & Development and Chief Scientific Officer at Certara, a company with a scientific team which includes almost 100 PhDs or MDs.
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