Dr Sebastian Polak is also a Senior Scientific Advisor in Certara UK, part of an international Certara company leading the team developing non-oral in silico absorption models. Dr Polak also holds tenure position at the Faculty of Pharmacy Jagiellonian University Medical College, Krakow, Poland (Professor of Biopharmacy) where he leads a multidisciplinary team of scientists and engineers working on applying various modelling and simulation approaches in drug development.
Always late, lacks assertiveness, likes motorcycles theoretically and even more in real life.

Utilization of PBPK models is a standard approach in the pharmaceutical industry realm, so why is cosmetics industry afraid of using this tool effectively for its benefit?

In vitro modelling and simulation using Physiologically Based Pharmacokinetic (PBPK) modelling has become an important part of the drug development process, both for novel and generic drug products [1]. Among others USFDA supports the use of modelling and simulation to assess: DDI risk, special population PK, bioequivalence between reference and test products [2]. Incorporation of mechanistic biophysically detailed model describing the behaviour of various semisolid formulations after application on the skin allows one to account for critical quality attributes (CQAs) and potentially optimize the formulation [3,4]. Hundreds of individual label claims have been approved based – at least partially – on the results of PBPK simulations with clinical trials waived. Utilization of PBPK/PBK models in the cosmetic industry seems to be limited [5]. My aim is to discuss this matter and together with the audience define potential reasons for this situation. I also hope to define routes of expansion of modelling and simulation-based approaches in the field of dermatokinetics assessment and formulation optimization of cosmetics.
References: (1) Shebley M. et al. Clin Pharmacol Ther. 2018 Jul;104(1):88-110. doi: 10.1002/cpt.1013 (2) Tsakalozou E, et al. AAPS J. 2023 Oct 2;25(6):96; doi:10.1208/s12248-023-00862-x. (3) Patel N et al. CPT PSP. 2022 Aug;11(8):1060-1084; doi:10.1002/psp4.12814. (4) Shah H, et al. Pharmaceutics. 2023 Mar 23;15(4):1040. doi: 10.3390/pharmaceutics15041040. (5) Krstevska A, et al. Pharmaceutics. 2022 Dec 28;15(1):107. doi: 10.3390/pharmaceutics15010107.