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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Detalles Bibliográficos
Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6032820/
https://www.ncbi.nlm.nih.gov/pubmed/29315504
http://dx.doi.org/10.1002/cpt.1013

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