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

Mohamad Shebley; Punam Sandhu; Arian Emami Riedmaier; Masoud Jamei; Rangaraj Narayanan; Aarti Patel; Sheila Annie Peters; Venkatesh Pilla Reddy; Ming Zheng; Loeckie de Zwart; Maud Beneton; Francois Bouzom; Jun Chen; Yuan Chen; Yumi Cleary; Christiane Collins; Gemma L. Dickinson; Nassim Djebli; Heidi J. Einolf; Iain Gardner; Felix Huth; Faraz Kazmi; Feras Khalil; Jing Lin; Aleksandrs Odinecs; Chirag Patel; Haojing Rong; Edgar Schuck; Pradeep Sharma; Shu Pei Wu; Yang Xu; Shinji Yamazaki; Kenta Yoshida; Malcolm Rowland

doi:10.1002/cpt.1013

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

Mohamad Shebley, Punam Sandhu, Arian Emami Riedmaier, Masoud Jamei, Rangaraj Narayanan, Aarti Patel, Sheila Annie Peters, Venkatesh Pilla Reddy, Ming Zheng, Loeckie de Zwart, Maud Beneton, Francois Bouzom, Jun Chen, Yuan Chen, Yumi Cleary, Christiane Collins, Gemma L. Dickinson, Nassim Djebli, Heidi J. Einolf, Iain GardnerFelix Huth, Faraz Kazmi, Feras Khalil, Jing Lin, Aleksandrs Odinecs, Chirag Patel, Haojing Rong, Edgar Schuck, Pradeep Sharma, Shu Pei Wu, Yang Xu, Shinji Yamazaki, Kenta Yoshida, Malcolm Rowland

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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.

Original language	English
Journal	Clinical Pharmacology and Therapeutics
Early online date	9 Jan 2018
DOIs	https://doi.org/10.1002/cpt.1013
Publication status	Published - 2018

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10.1002/cpt.1013Licence: CC BY-NC-ND

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Shebley, M., Sandhu, P., Emami Riedmaier, A., Jamei, M., Narayanan, R., Patel, A., Peters, S. A., Reddy, V. P., Zheng, M., de Zwart, L., Beneton, M., Bouzom, F., Chen, J., Chen, Y., Cleary, Y., Collins, C., Dickinson, G. L., Djebli, N., Einolf, H. J., ... Rowland, M. (2018). Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective. Clinical Pharmacology and Therapeutics. https://doi.org/10.1002/cpt.1013

@article{cd854a1c3d1c4712906073c5348cacda,

title = "Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective",

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.",

author = "Mohamad Shebley and Punam Sandhu and {Emami Riedmaier}, Arian and Masoud Jamei and Rangaraj Narayanan and Aarti Patel and Peters, {Sheila Annie} and Reddy, {Venkatesh Pilla} and Ming Zheng and {de Zwart}, Loeckie and Maud Beneton and Francois Bouzom and Jun Chen and Yuan Chen and Yumi Cleary and Christiane Collins and Dickinson, {Gemma L.} and Nassim Djebli and Einolf, {Heidi J.} and Iain Gardner and Felix Huth and Faraz Kazmi and Feras Khalil and Jing Lin and Aleksandrs Odinecs and Chirag Patel and Haojing Rong and Edgar Schuck and Pradeep Sharma and Wu, {Shu Pei} and Yang Xu and Shinji Yamazaki and Kenta Yoshida and Malcolm Rowland",

year = "2018",

doi = "10.1002/cpt.1013",

language = "English",

journal = "Clinical Pharmacology and Therapeutics",

issn = "0009-9236",

publisher = "Springer Nature",

}

Shebley, M, Sandhu, P, Emami Riedmaier, A, Jamei, M, Narayanan, R, Patel, A, Peters, SA, Reddy, VP, Zheng, M, de Zwart, L, Beneton, M, Bouzom, F, Chen, J, Chen, Y, Cleary, Y, Collins, C, Dickinson, GL, Djebli, N, Einolf, HJ, Gardner, I, Huth, F, Kazmi, F, Khalil, F, Lin, J, Odinecs, A, Patel, C, Rong, H, Schuck, E, Sharma, P, Wu, SP, Xu, Y, Yamazaki, S, Yoshida, K & Rowland, M 2018, 'Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective', Clinical Pharmacology and Therapeutics. https://doi.org/10.1002/cpt.1013

TY - JOUR

T1 - Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions

T2 - A Consortium Perspective

AU - Shebley, Mohamad

AU - Sandhu, Punam

AU - Emami Riedmaier, Arian

AU - Jamei, Masoud

AU - Narayanan, Rangaraj

AU - Patel, Aarti

AU - Peters, Sheila Annie

AU - Reddy, Venkatesh Pilla

AU - Zheng, Ming

AU - de Zwart, Loeckie

AU - Beneton, Maud

AU - Bouzom, Francois

AU - Chen, Jun

AU - Chen, Yuan

AU - Cleary, Yumi

AU - Collins, Christiane

AU - Dickinson, Gemma L.

AU - Djebli, Nassim

AU - Einolf, Heidi J.

AU - Gardner, Iain

AU - Huth, Felix

AU - Kazmi, Faraz

AU - Khalil, Feras

AU - Lin, Jing

AU - Odinecs, Aleksandrs

AU - Patel, Chirag

AU - Rong, Haojing

AU - Schuck, Edgar

AU - Sharma, Pradeep

AU - Wu, Shu Pei

AU - Xu, Yang

AU - Yamazaki, Shinji

AU - Yoshida, Kenta

AU - Rowland, Malcolm

PY - 2018

Y1 - 2018

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AB - 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.

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U2 - 10.1002/cpt.1013

DO - 10.1002/cpt.1013

M3 - Article

AN - SCOPUS:85041351758

SN - 0009-9236

JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

ER -

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

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