Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective

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 va...

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Salvato in:
Dettagli Bibliografici
Pubblicato in:Clin Pharmacol Ther
Autori principali: 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
Natura: Artigo
Lingua:Inglês
Pubblicazione: John Wiley and Sons Inc. 2018
Soggetti:
Reviews
Accesso online:https://ncbi.nlm.nih.gov/pmc/articles/PMC6032820/
https://ncbi.nlm.nih.gov/pubmed/29315504
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.1013
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