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Role of physiologically-based pharmacokinetics in regulatory submissions

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Role of physiologically-based pharmacokinetics in regulatory submissions

Virtual Event Virtual Event

May 26 @ 15:00 16:00 CEST

Physiologically based pharmacokinetic (PBPK) is an approach that help predict the absorption, distribution, metabolism and excretion (ADME) properties of candidate drugs in animal/human and evaluate the effects of intrinsic (e.g. organ dysfunction, age, genetics) and extrinsic (e.g. diet, smoking habit, drug-drug interactions) factors, alone or in combinations, on drug exposure, during drug discovery and development process. Currently, different software (i.e. SimCYP, PK-Sim, GastroPlus etc) are available to perform the PBPK simulations, and the simulations are often part of regulatory submissions of small molecules and biologic new drug candidates (CD).

If successful, the simulations may complement or replace the experimental study and/or help to explain different findings, scenarios related to estimation of exposure and effect of new CDs. Therefore, the regulatory authorities i.e. EMA and FDA provided guidelines, which described how to report PBPK models and simulations in a regulatory context.
Dr Gaugaz in her presentation will discuss role of PBPK simulations from small molecules and biologic CDs in submissions, from regulatory point of view.

Dr Fabienne Gaugaz
Pharmacokinetics Assessor,
Medical Products Agency (Läkemedelsverket)
Dag Hammarskjölds Väg 42,
752 37 Uppsala

Dr Fabienne Gaugaz is pharmacokinetics assessor at the Swedish Medical Product Agency (Läkemedelsverket), which entails the evaluation of the pharmacologically-based pharmacokinetics (PBPK) simulations related to small molecules and biologic drug candidates. Dr Gaugaz previously worked at Bayer (Wuppertal, Germany) as lab head of research pharmacokinetics. Fabienne made her postdoc project at Karolinska Institutet (KI) and Uppsala University (UU). Dr Gaugaz obtained her Ph.D. in 2013 in pharmaceutical biology at the Institute of Pharmaceutical Sciences, Swiss Federal Institute of Technology (ETH) in Zürich, Switzerland and her M.Sc. in Pharmacy, ETH, Zürich, Switzerland.