Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Oct:60 Suppl 1:S160-S178.
doi: 10.1002/jcph.1767.

Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical Pharmacology

Xinyuan Zhang  1 , Yuching Yang  1 , Manuela Grimstein  1 , Jianghong Fan  1 , Joseph A Grillo  1 , Shiew-Mei Huang  1 , Hao Zhu  1 , Yaning Wang  1
Affiliations

Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical Pharmacology

Xinyuan Zhang et al. J Clin Pharmacol. 2020 Oct.

Abstract

Since 2016, results from physiologically based pharmacokinetic (PBPK) analyses have been routinely found in the clinical pharmacology section of regulatory applications submitted to the US Food and Drug Administration (FDA). In 2018, the Food and Drug Administration's Office of Clinical Pharmacology published a commentary summarizing the application of PBPK modeling in the submissions it received between 2008 and 2017 and its impact on prescribing information. In this commentary, we provide an update on the application of PBPK modeling in submissions received between 2018 and 2019 and highlight a few notable examples.

Keywords: MIDD (model-informed drug development); PBPK; clinical pharmacology (CPH); drug-drug interactions; modeling and simulation; pharmacokinetics and drug metabolism.

PubMed Disclaimer

References

    1. Grimstein M, Yang Y, Zhang X, et al., Physiologically based pharmacokinetic modeling in regulatory science: an update from the U.S. Food and Drug Administration's Office of Clinical Pharmacology. J Pharm Sci 2019;108(1):21-25.
    1. 21 C.F.R. 201.56(a)(1): Requirements on content and format of labeling for human prescription drug and biological products. https://www.ecfr.gov/cgi-bin/text-idx?SID=c2a78114892db0881313acb4203a33.... Accessed October 26, 2020.
    1. US Food and Drug Administration. Guidance for Industry: Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products - Content and Format. https://www.fda.gov/media/74346/download. Published 2016. Accessed October 26, 2020.
    1. US Food and Drug Administration. Model-Informed Drug Development Pilot Program. https://www.fda.gov/drugs/development-resources/model-informed-drug-deve.... Accessed October 26, 2020.
    1. US Food and Drug Administration. NDA 207924 Baricitinib Clinical Pharmacology and Biopharmaceutics Review(s). https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207924Orig1s000C.... Published 2018. Accessed October 26, 2020.

MeSH terms

Substances

LinkOut - more resources