Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective. Issue 1 (2nd February 2018)

• Record Type: Journal Article
• Authors: Shebley, Mohamad; Sandhu, Punam; Emami Riedmaier, Arian; Jamei, Masoud; Narayanan, Rangaraj; Patel, Aarti; Peters, Sheila Annie; Reddy, Venkatesh Pilla; Zheng, Ming; de Zwart, Loeckie; Beneton, Maud; Bouzom, Francois; Chen, Jun; Chen, Yuan; Cleary, Yumi; Collins, Christiane; Dickinson, Gemma L.; Djebli, Nassim; Einolf, Heidi J.; Gardner, Iain; Huth, Felix; Kazmi, Faraz; Khalil, Feras; Lin, Jing; Odinecs, Aleksandrs; Patel, Chirag; Rong, Haojing; Schuck, Edgar; Sharma, Pradeep; Wu, Shu‐Pei; Xu, Yang; Yamazaki, Shinji; Yoshida, Kenta; Rowland, Malcolm;
• Is Part Of: Clinical pharmacology & therapeutics. Volume 104:Issue 1(2018)
• Page Start: 88
• Page End: 110
• Publication Date: 2018-02-02
• Subjects: Pharmacology -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1002/cpt.1013
• Languages: English
• ISSNs: 0009-9236

Abstract

Abstract : This work provides a perspective on the qualification and verification of physiologically based pharmacokinetic (PBPK) platforms/models intended for regulatory submission based on the collective experience of the Simcyp Consortium members. Examples of regulatory submission of PBPK analyses across various intended applications are presented and discussed. European Medicines Agency (EMA) and US Food and Drug Administration (FDA) recent draft guidelines regarding PBPK analyses and reporting are encouraging, and to advance the use and acceptability of PBPK analyses, more clarity and flexibility are warranted.