Literature DB >> 29603191

Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop.

Lanyan Fang1, Myong-Jin Kim1, Zhichuan Li1, Yaning Wang2, Charles E DiLiberti3, Jessie Au4, Andrew Hooker5, Murray P Ducharme6, Robert Lionberger1, Liang Zhao1.   

Abstract

On October 2nd and 3rd , 2017, the US Food and Drug Administration (FDA) hosted a public workshop titled "Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review."1 This report summarizes Session 2 of the public workshop: "Model Informed Drug Development and Review for Generic Products." The session focused on the application of quantitative methods and modeling in modernizing the generic drug development and review.
© 2018 American Society for Clinical Pharmacology and Therapeutics.

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Year:  2018        PMID： 29603191     DOI： 10.1002/cpt.1065

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  9 in total

Review 1.  Systemic Bioequivalence Is Unlikely to Equal Target Site Bioequivalence for Nanotechnology Oncologic Products.

Authors:  Jessie L-S Au; Ze Lu; Roberto A Abbiati; M Guillaume Wientjes
Journal:  AAPS J       Date:  2019-02-01       Impact factor: 4.009

Review 2.  Scientific considerations for global drug development.

Authors:  Jennifer L Wilson; Kit Wun Kathy Cheung; Lawrence Lin; Elizabeth A E Green; Analia I Porrás; Ling Zou; David Mukanga; Paul A Akpa; Delese Mimi Darko; Rae Yuan; Sheng Ding; Wiltshire C N Johnson; Howard A Lee; Emer Cooke; Carl C Peck; Steven E Kern; Dan Hartman; Yoshikazu Hayashi; Peter W Marks; Russ B Altman; Murray M Lumpkin; Kathleen M Giacomini; Terrence F Blaschke
Journal:  Sci Transl Med       Date:  2020-07-29       Impact factor: 17.956

Review 3.  Target Site Delivery and Residence of Nanomedicines: Application of Quantitative Systems Pharmacology.

Authors:  Jessie L-S Au; Roberto A Abbiati; M Guillaume Wientjes; Ze Lu
Journal:  Pharmacol Rev       Date:  2019-04       Impact factor: 25.468

4.  Is It Time to Use Modeling of Cellular Transporter Homeostasis to Inform Drug-Drug Interaction Studies: Theoretical Considerations.

Authors:  Roberto A Abbiati; M Guillaume Wientjes; Jessie L-S Au
Journal:  AAPS J       Date:  2021-08-25       Impact factor: 4.009

5.  The World Health Organization Prequalification Program and Clinical Pharmacology in 2030.

Authors:  Terrence F Blaschke; Murray Lumpkin; Daniel Hartman
Journal:  Clin Pharmacol Ther       Date:  2019-11-26       Impact factor: 6.875

Review 6.  Review: Role of Model-Informed Drug Development Approaches in the Lifecycle of Drug Development and Regulatory Decision-Making.

Authors:  Rajanikanth Madabushi; Paul Seo; Liang Zhao; Million Tegenge; Hao Zhu
Journal:  Pharm Res       Date:  2022-05-12       Impact factor: 4.580

7.  Quantitative methods and modeling to assess COVID-19-interrupted in vivo pharmacokinetic bioequivalence studies with two reference batches.

Authors:  Yuqing Gong; Kairui Feng; Peijue Zhang; Jieon Lee; Yuzhuo Pan; Zhen Zhang; Zhanglin Ni; Tao Bai; Miyoung Yoon; Bing Li; Carol Y Kim; Lanyan Fang; Liang Zhao
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2022-04-20

Review 8.  Current trends in drug metabolism and pharmacokinetics.

Authors:  Yuhua Li; Qiang Meng; Mengbi Yang; Dongyang Liu; Xiangyu Hou; Lan Tang; Xin Wang; Yuanfeng Lyu; Xiaoyan Chen; Kexin Liu; Ai-Ming Yu; Zhong Zuo; Huichang Bi
Journal:  Acta Pharm Sin B       Date:  2019-10-18       Impact factor: 11.413

9.  A Quantitative Pharmacology Model of Exosome-Mediated Drug Efflux and Perturbation-Induced Synergy.

Authors:  Jin Wang; Bertrand Z Yeung; M Guillaume Wientjes; Minjian Cui; Cody J Peer; Ze Lu; William D Figg; Sukyung Woo; Jessie L-S Au
Journal:  Pharmaceutics       Date:  2021-06-30       Impact factor: 6.321
  9 in total

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