Literature DB >> 31081932

The US Food and Drug Administration's Model-Informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact.

Rajanikanth Madabushi1, Jessica M Benjamin1, Renmeet Grewal1, Michael A Pacanowski1, David G Strauss1, Yaning Wang1, Hao Zhu1, Issam Zineh1.   

Abstract

Year:  2019        PMID： 31081932     DOI： 10.1002/cpt.1457

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


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  8 in total

Review 1.  A Systematic Review of the Efforts and Hindrances of Modeling and Simulation of CAR T-cell Therapy.

Authors:  Ujwani Nukala; Marisabel Rodriguez Messan; Osman N Yogurtcu; Xiaofei Wang; Hong Yang
Journal:  AAPS J       Date:  2021-04-09       Impact factor: 4.009

Review 2.  Personalized Cancer Vaccines: Clinical Landscape, Challenges, and Opportunities.

Authors:  Colby S Shemesh; Joy C Hsu; Iraj Hosseini; Ben-Quan Shen; Anand Rotte; Patrick Twomey; Sandhya Girish; Benjamin Wu
Journal:  Mol Ther       Date:  2020-09-30       Impact factor: 11.454

Review 3.  End-to-end application of model-informed drug development for ertugliflozin, a novel sodium-glucose cotransporter 2 inhibitor.

Authors:  Daryl J Fediuk; Gianluca Nucci; Vikas K Dawra; Ernesto Callegari; Susan Zhou; Cynthia J Musante; Yali Liang; Kevin Sweeney; Vaishali Sahasrabudhe
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2021-05-15

Review 4.  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

5.  Development of a pediatric physiologically-based pharmacokinetic model to support recommended dosing of atezolizumab in children with solid tumors.

Authors:  Weize Huang; Felix Stader; Phyllis Chan; Colby S Shemesh; Yuan Chen; Katherine L Gill; Hannah M Jones; Linzhong Li; Gianluca Rossato; Benjamin Wu; Jin Y Jin; Pascal Chanu
Journal:  Front Pharmacol       Date:  2022-09-26       Impact factor: 5.988

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

Authors:  Colleen Kuemmel; Yuching Yang; Xinyuan Zhang; Jeffry Florian; Hao Zhu; Million Tegenge; Shiew-Mei Huang; Yaning Wang; Tina Morrison; Issam Zineh
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2019-11-10

7.  Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs, Gaps, and Challenges.

Authors:  Flora T Musuamba; Roberta Bursi; Efthymios Manolis; Kristin Karlsson; Alexander Kulesza; Eulalie Courcelles; Jean-Pierre Boissel; Raphaëlle Lesage; Cécile Crozatier; Emmanuelle M Voisin; Cécile F Rousseau; Thierry Marchal; Rossana Alessandrello; Liesbet Geris
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2020-04-01

8.  Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility.

Authors:  Flora T Musuamba; Ine Skottheim Rusten; Raphaëlle Lesage; Giulia Russo; Roberta Bursi; Luca Emili; Gaby Wangorsch; Efthymios Manolis; Kristin E Karlsson; Alexander Kulesza; Eulalie Courcelles; Jean-Pierre Boissel; Cécile F Rousseau; Emmanuelle M Voisin; Rossana Alessandrello; Nuno Curado; Enrico Dall'ara; Blanca Rodriguez; Francesco Pappalardo; Liesbet Geris
Journal:  CPT Pharmacometrics Syst Pharmacol       Date:  2021-07-13
  8 in total

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