Current Scientific Considerations to Verify Physiologically‐Based Pharmacokinetic Models and Their Implications for Locally Acting Products-Reference-Cited by-同舟云学术

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

Published:2019-06 Issue:6 Volume:8 Page:347-351
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Zhao Liang¹,Seo Paul²,Lionberger Robert³

Affiliation:

1. Division of Quantitative Methods and ModelingOffice of Research and StandardsOffice of Generic DrugsCenter for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

2. Division of BiopharmaceuticsOffice of New Drug ProductsOffice of Pharmaceutical QualityCenter for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

3. Office of Research and StandardsOffice of Generic DrugsCenter for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12421

Reference10 articles.

1. Application of Physiologically Based Pharmacokinetic (PBPK) Modeling to Support Dose Selection: Report of an FDA Public Workshop on PBPK

2. Generating Model Integrated Evidence for Generic Drug Development and Assessment

3. Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

4. European Medicines Agency. Guideline on the qualification and reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation.

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