Current Scientific Considerations to Verify Physiologically-Based Pharmacokinetic Models and Their Implications for Locally Acting Products

Affiliations

¹ Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
² Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
³ Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Liang Zhao et al. CPT Pharmacometrics Syst Pharmacol. 2019 Jun.

. 2019 Jun;8(6):347-351.

doi: 10.1002/psp4.12421.

¹ Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
² Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
³ Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

No abstract available

Conflict of interest statement

The authors declared no competing interests for this work.

1. Wagner, C. et al Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA Public Workshop on PBPK. CPT Pharmacometrics Syst. Pharmacol. 4, 226–230 (2015). - PMC - PubMed
1. Zhao, L. , Kim, M.J. , Zhang, L. & Lionberger, R. State of art: generating model integrated evidence for generic drug development and assessment. Clin. Pharmacol. Ther. 105, 338–349 (2019). - PubMed
1. Zhang, X. et al Mechanistic oral absorption modeling and simulation for formulation development and bioequivalence evaluation: report of an FDA Public Workshop. CPT Pharmacometrics Syst. Pharmacol. 6, 492–495 (2017). - PMC - PubMed
1. European Medicines Agency. Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation <https://www.ema.europa.eu/documents/scientific-guideline/guideline-quali...>.
1. American Society of Mechanical Engineers . Verification and Validation in Computational Modeling of Medical Devices (American Society of Mechanical Engineers, New York, 2018).