Literature DB >> 35790617

Applications of Model Informed Drug Development (MIDD) in Drug Development Lifecycle and Regulatory Review.

Amitava Mitra1,2, Yaning Wang3.   

Abstract

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Year:  2022        PMID： 35790617     DOI： 10.1007/s11095-022-03327-6

Source DB:  PubMed          Journal:  Pharm Res        ISSN： 0724-8741            Impact factor:   4.580


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  6 in total

Review 1.  The Use of Physiologically Based Pharmacokinetic Analyses-in Biopharmaceutics Applications -Regulatory and Industry Perspectives.

Authors:  Om Anand; Xavier J H Pepin; Vidula Kolhatkar; Paul Seo
Journal:  Pharm Res       Date:  2022-05-18       Impact factor: 4.580

2.  The Effects of Solid Particle Containing Inks on the Printing Quality of Porous Pharmaceutical Structures Fabricated by 3D Semi-Solid Extrusion Printing.

Authors:  Xin-Yi Teoh; Bin Zhang; Peter Belton; Siok-Yee Chan; Sheng Qi
Journal:  Pharm Res       Date:  2022-06-03       Impact factor: 4.580

Review 3.  Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective.

Authors:  Wen Lin; Yuan Chen; Jashvant D Unadkat; Xinyuan Zhang; Di Wu; Tycho Heimbach
Journal:  Pharm Res       Date:  2022-05-13       Impact factor: 4.580

Review 4.  Role of Disease Progression Models in Drug Development.

Authors:  Jeffrey S Barrett; Tim Nicholas; Karim Azer; Brian W Corrigan
Journal:  Pharm Res       Date:  2022-04-11       Impact factor: 4.580

5.  Improved Confidence in a Confirmatory Stage by Application of Item-Based Pharmacometrics Model: Illustration with a Phase III Active Comparator-Controlled Trial in COPD Patients.

Authors:  Carolina Llanos-Paez; Claire Ambery; Shuying Yang; Misba Beerahee; Elodie L Plan; Mats O Karlsson
Journal:  Pharm Res       Date:  2022-03-01       Impact factor: 4.580

6.  Applications of Quantitative Systems Pharmacology (QSP) in Drug Development for NAFLD and NASH and Its Regulatory Application.

Authors:  Scott Q Siler
Journal:  Pharm Res       Date:  2022-05-24       Impact factor: 4.580
  6 in total

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