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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...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2018
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| Materias: | |
| 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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| author | 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 |
| author_facet | 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 |
| author_sort | Shebley, Mohamad |
| collection | PubMed |
| description | 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. |
| format | Online Article Text |
| id | pubmed-6032820 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2018 |
| publisher | John Wiley and Sons Inc. |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-60328202018-07-09 Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective 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 Clin Pharmacol Ther Reviews 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. John Wiley and Sons Inc. 2018-02-02 2018-07 /pmc/articles/PMC6032820/ /pubmed/29315504 http://dx.doi.org/10.1002/cpt.1013 Text en © 2018, The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
| spellingShingle | Reviews 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 Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective |
| title | Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective |
| title_full | Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective |
| title_fullStr | Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective |
| title_full_unstemmed | Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective |
| title_short | Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective |
| title_sort | physiologically based pharmacokinetic model qualification and reporting procedures for regulatory submissions: a consortium perspective |
| topic | Reviews |
| url | 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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