Report from the EMA workshop on qualification and reporting of physiologically based pharmacokinetic (PBPK) modeling and simulation
Open accessAbstract
On Nov 21, 2016, the European Medicines Agency (EMA) hosted a workshop to discuss its draft guideline on qualification and reporting of physiologically based pharmacokinetic (PBPK) analysis.1 Published on July 21, 2016, the draft PBPK guideline is currently under the period of public comments.
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The European Medicines Agency encourages PSA to characterise the level of uncertainty in PBPK models.
“The European Medicines Agency encourages PSA to characterise the level of uncertainty in PBPK models [7, 66].”
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References 3 · Cited by 45
Research works printed but not linked: 1
- [1]“Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation.” < http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/07/WC500211315.pdf>. PMC5321806 28035755
- Authors
- Zhao, P.
- Affiliations
- United States Food and Drug Administration (US)
- Corresponding author
- Zhao, P
- ORCID
- Zhao, P
- Venue
- CPT: Pharmacometrics & Systems Pharmacology
- Publisher
- Wiley
- Published
- 2017-02
- Volume
- 6
- Issue
- 2
- Pages
- 71-72
- ISSN
- 2163-8306 (ISSN-L)
- PMC
- PMC5321806
- OpenAlex
- W2562558875
- Cited by
- 45
- References
- 3
- Citations by year
- 2025: 2 · 2024: 4 · 2023: 3 · 2022: 5 · 2021: 8 · 2020: 2 · 2019: 9 · 2018: 7 · 2017: 2 · 2016: 1 · 2015: 2
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- CPT Pharmacometrics & Systems Pharmacology (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Keywords
- physiologically based pharmacokinetic modeling, model qualification, reporting guidelines, European Medicines Agency, regulatory guidelines, public comment period
- MeSH terms
- Computer Simulation, Pharmaceutical Preparations, Humans, Models, Biological, Pharmacokinetics, Guidelines as Topic
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