Literature DB >> 31162631

Model-Informed Drug Development: A Regulatory Perspective on Progress.

Hao Zhu1, Shiew Mei Huang1, Rajanikanth Madabushi1, David G Strauss1, Yaning Wang1, Issam Zineh1.   

Abstract

Year:  2019        PMID： 31162631     DOI： 10.1002/cpt.1475

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


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  4 in total

Review 1.  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

2.  Drug Clearance in Neonates: A Combination of Population Pharmacokinetic Modelling and Machine Learning Approaches to Improve Individual Prediction.

Authors:  Bo-Hao Tang; Zheng Guan; Karel Allegaert; Yue-E Wu; Efthymios Manolis; Stephanie Leroux; Bu-Fan Yao; Hai-Yan Shi; Xiao Li; Xin Huang; Wen-Qi Wang; A-Dong Shen; Xiao-Ling Wang; Tian-You Wang; Chen Kou; Hai-Yan Xu; Yue Zhou; Yi Zheng; Guo-Xiang Hao; Bao-Ping Xu; Alison H Thomson; Edmund V Capparelli; Valerie Biran; Nicolas Simon; Bernd Meibohm; Yoke-Lin Lo; Remedios Marques; Jose-Esteban Peris; Irja Lutsar; Jumpei Saito; Jacobus Burggraaf; Evelyne Jacqz-Aigrain; John van den Anker; Wei Zhao
Journal:  Clin Pharmacokinet       Date:  2021-05-27       Impact factor: 5.577

Review 3.  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

4.  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
  4 in total

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