Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation-Reference-Cited by-同舟云学术

Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation

Published:2019-11-10 Issue:1 Volume:9 Page:21-28
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacometrics Syst. Pharmacol.

Author:

Kuemmel Colleen¹,Yang Yuching¹,Zhang Xinyuan¹,Florian Jeffry¹,Zhu Hao¹,Tegenge Million²,Huang Shiew‐Mei¹,Wang Yaning¹,Morrison Tina³,Zineh Issam¹

Affiliation:

1. Office of Clinical Pharmacology Office of Translational Sciences Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

2. Office of Biostatistics and Epidemiology Center for Biologics Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

3. Office of Science and Engineering Laboratories Center for Devices and Radiological Health US 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/psp4.12479

Reference21 articles.

1. Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations

2. Translational Quantitative Systems Pharmacology in Drug Development: from Current Landscape to Good Practices

3. A model qualification method for mechanistic physiological QSP models to support model‐informed drug development

4. Requirements to Establishing Confidence in Physiologically Based Pharmacokinetic (PBPK) Models and Overcoming Some of the Challenges to Meeting Them

5. Establishing Good Practices for Exposure–Response Analysis of Clinical Endpoints in Drug Development

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