Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report-Reference-Cited by-同舟云学术

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

Published:2023-01-04 Issue: Volume: Page:
ISSN:2163-8306
Container-title:CPT: Pharmacometrics & Systems Pharmacology
language:en
Short-container-title:CPT Pharmacom & Syst Pharma

Author:

Wu Fang¹,Mousa Youssef¹,Raines Kimberly²,Bode Chris³,Tsang Yu Chung⁴,Cristofoletti Rodrigo⁵,Zhang Hongling⁶,Heimbach Tycho⁷,Fang Lanyan¹,Kesisoglou Filippos⁷,Mitra Amitava⁸,Polli James⁹^ORCID,Kim Myong‐Jin¹,Fan Jianghong¹⁰,Zolnik Banu S.²,Sun Duxin¹¹,Zhang Yi¹,Zhao Liang¹

Affiliation:

1. Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER) US Food and Drug Administration (FDA) Maryland Silver Spring USA

2. Office of New Drug Products (ONDP), Office of Pharmaceutical Quality (OPQ), CDER U.S. FDA Maryland Silver Spring USA

3. Absorption Systems LLC Pennsylvania Eaton USA

4. Apotex Inc. Ontario Toronto Canada

5. University of Florida Florida Gainesville USA

6. Office of Bioequivalence, OGD, CDER, U.S. FDA Maryland Silver Spring USA

7. Merck & Co., Inc. New Jersey Rahway USA

8. Janssen Research & Development New Jersey Raritan USA

9. University of Maryland Maryland College Park USA

10. Office of Clinical Pharmacology, Office of Translational Sciences, CDER, U.S. FDA Maryland Silver Spring USA

11. University of Michigan Michigan Ann Arbor USA

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/psp4.12907

Reference19 articles.

1. FDA‐CRCG workshop: Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches.2021.https://complexgenerics.org/PBPK2021/. Accessed September 18 2022.

2. U.S.FDA guidance for industry.The use of physiologically based pharmacokinetic analyses‐biopharmaceutics applications for oral drug product development manufacturing changes and controls.2020.https://www.fda.gov/media/142500/download. Accessed September 18 2022

3. WuF.PBPK Absorption Modeling to Support Risk Assessment and Biowaiver for Generic Oral Products.2021.https://complexgenerics.org/media/SOP/complexgenerics/pdf/Conference‐Slides/D2‐03%202021_PBPK_workshop_Fang%20Wu_Presentation_Final_Modified_for_Posting.pdf. Accessed September 18 2022.

4. U.S. FDA guidance for industry.Evaluation of Gastric pH‐Dependent Drug Interactions With Acid‐Reducing Agents: Study Design Data Analysis and Clinical Implications Guidance for Industry.2020.https://www.fda.gov/media/144026/download. Accessed September 18 2022.

5. Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations

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3. Advances in quantitative methods and modeling for complex generic drugs and opportunities to hybridize learnings between innovator and generic drug developers;CPT: Pharmacometrics & Systems Pharmacology;2023-04-27

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