Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.
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ABSTRACT:
SUBMITTER: Shebley M
PROVIDER: S-EPMC6032820 | biostudies-other | 2018 Jul
REPOSITORIES: biostudies-other
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Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.
Shebley Mohamad M Sandhu Punam P Emami Riedmaier Arian A Jamei Masoud M Narayanan Rangaraj R Patel Aarti A Peters Sheila Annie SA Reddy Venkatesh Pilla VP Zheng Ming M de Zwart Loeckie L Beneton Maud M Bouzom Francois F Chen Jun J Chen Yuan Y Cleary Yumi Y Collins Christiane C Dickinson Gemma L GL Djebli Nassim N Einolf Heidi J HJ Gardner Iain I Huth Felix F Kazmi Faraz F Khalil Feras F Lin Jing J Odinecs Aleksandrs A Patel Chirag C Rong Haojing H Schuck Edgar E Sharma Pradeep P Wu Shu-Pei SP Xu Yang Y Yamazaki Shinji S Yoshida Kenta K Rowland Malcolm M
Clinical pharmacology and therapeutics 20180202 1
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 enc ...[more]
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