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Physiologically-Based Pharmacokinetic Models for Evaluating Membrane Transporter Mediated Drug-Drug Interactions: Current Capabilities, Case Studies, Future Opportunities, and Recommendations.
Taskar, Kunal S; Pilla Reddy, Venkatesh; Burt, Howard; Posada, Maria M; Varma, Manthena; Zheng, Ming; Ullah, Mohammed; Emami Riedmaier, Arian; Umehara, Ken-Ichi; Snoeys, Jan; Nakakariya, Masanori; Chu, Xiaoyan; Beneton, Maud; Chen, Yuan; Huth, Felix; Narayanan, Rangaraj; Mukherjee, Dwaipayan; Dixit, Vaishali; Sugiyama, Yuichi; Neuhoff, Sibylle.
Afiliación
  • Taskar KS; GlaxoSmithKline, DMPK, In Vitro In Vivo Translation, GSK R&D, Ware, UK.
  • Pilla Reddy V; AstraZeneca, Modelling and Simulation, Early Oncology DMPK, Oncology R&D, AstraZeneca, Cambridge, UK.
  • Burt H; Simcyp-Division, Certara UK Ltd., Sheffield, UK.
  • Posada MM; Eli Lilly & Company, Indianapolis, Indiana, USA.
  • Varma M; Pfizer Inc., Groton, Connecticut, USA.
  • Zheng M; Bristol-Myers Squibb Company, Princeton, New Jersey, USA.
  • Ullah M; Roche Innovation Center, Basel, Switzerland.
  • Emami Riedmaier A; AbbVie Inc., North Chicago, Illinois, USA.
  • Umehara KI; Roche Innovation Center, Basel, Switzerland.
  • Snoeys J; Janssen Research and Development, Beerse, Belgium.
  • Nakakariya M; Takeda Pharmaceutical Company Ltd., Kanagawa, Japan.
  • Chu X; Merck Sharp & Dohme Corp., Kenilworth, New Jersey, USA.
  • Beneton M; Servier, Centre-Val de Loire, France.
  • Chen Y; Genentech, San Francisco, California, USA.
  • Huth F; Novartis, Basel, Switzerland.
  • Narayanan R; Shire, Lexington, Massachusetts, USA.
  • Mukherjee D; AbbVie Inc., North Chicago, Illinois, USA.
  • Dixit V; Eisai Inc., Woodliff Lake, New Jersey, USA.
  • Sugiyama Y; Sugiyama Laboratory, Riken, Yokohama, Japan.
  • Neuhoff S; Simcyp-Division, Certara UK Ltd., Sheffield, UK.
Clin Pharmacol Ther ; 107(5): 1082-1115, 2020 05.
Article en En | MEDLINE | ID: mdl-31628859
Physiologically-based pharmacokinetic (PBPK) modeling has been extensively used to quantitatively translate in vitro data and evaluate temporal effects from drug-drug interactions (DDIs), arising due to reversible enzyme and transporter inhibition, irreversible time-dependent inhibition, enzyme induction, and/or suppression. PBPK modeling has now gained reasonable acceptance with the regulatory authorities for the cytochrome-P450-mediated DDIs and is routinely used. However, the application of PBPK for transporter-mediated DDIs (tDDI) in drug development is relatively uncommon. Because the predictive performance of PBPK models for tDDI is not well established, here, we represent and discuss examples of PBPK analyses included in regulatory submission (the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA)) across various tDDIs. The goal of this collaborative effort (involving scientists representing 17 pharmaceutical companies in the Consortium and from academia) is to reflect on the use of current databases and models to address tDDIs. This challenges the common perceptions on applications of PBPK for tDDIs and further delves into the requirements to improve such PBPK predictions. This review provides a reflection on the current trends in PBPK modeling for tDDIs and provides a framework to promote continuous use, verification, and improvement in industrialization of the transporter PBPK modeling.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas de Transporte de Membrana / Interacciones Farmacológicas / Modelos Biológicos Tipo de estudio: Prognostic_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Ther Año: 2020 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Proteínas de Transporte de Membrana / Interacciones Farmacológicas / Modelos Biológicos Tipo de estudio: Prognostic_studies Límite: Humans Idioma: En Revista: Clin Pharmacol Ther Año: 2020 Tipo del documento: Article Pais de publicación: Estados Unidos