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Shebley, Mohamad; Sandhu, Punam; Emami Riedmaier, Arian; Jamei, Masoud; Narayanan, Rangaraj; Patel, Aarti; Peters, Sheila Annie; Reddy, Venkatesh Pilla; Zheng, Ming; 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
Clinical pharmacology and therapeutics, July 2018, Letnik: 104, Številka: 1Journal Article
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.
