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In Vitro Biopredictive Methods: A Workshop Summary Report.
Pepin, Xavier J H; Dressman, Jennifer; Parrott, Neil; Delvadia, Poonam; Mitra, Amitava; Zhang, Xinyuan; Babiskin, Andrew; Kolhatkar, Vidula; Seo, Paul; Taylor, Lynne S; Sjögren, Erik; Butler, James M; Kostewicz, Edmund; Tannergren, Christer; Koziolek, Mirko; Kesisoglou, Filippos; Dallmann, André; Zhao, Yang; Suarez-Sharp, Sandra.
Afiliación
  • Pepin XJH; New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK. Electronic address: Xavier.pepin@astrazeneca.com.
  • Dressman J; Fraunhofer Institute for Molecular Biology and Applied Ecology and Goethe University, Frankfurt, Germany.
  • Parrott N; Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
  • Delvadia P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Mitra A; Clinical Pharmacology and Pharmacometrics, Janssen Research & Development, Spring House, PA, USA.
  • Zhang X; Division of Pharmacometrics, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Babiskin A; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Kolhatkar V; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Seo P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Taylor LS; Purdue University, College of Pharmacy, West Lafayette, IN, USA.
  • Sjögren E; Pharmetheus, Uppsala, Sweden.
  • Butler JM; Biopharmaceutics, Drug Product Design & Dev, GlaxoSmithKline R&D, Ware, UK.
  • Kostewicz E; Institute of Pharmaceutical Technology, Goethe University, Frankfurt, Germany.
  • Tannergren C; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden.
  • Koziolek M; University of Greifswald, Institute of Pharmacy, Greifswald, Germany; Current: NCE Formulation Sciences, AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.
  • Kesisoglou F; Pharmaceutical Sciences, Merck & Co., Inc., Kenilworth, NJ, USA.
  • Dallmann A; Clinical Pharmacometrics, Research & Development, Pharmaceuticals, Bayer AG, Leverkusen, Germany.
  • Zhao Y; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
  • Suarez-Sharp S; Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, CA 93534, USA.
J Pharm Sci ; 110(2): 567-583, 2021 02.
Article en En | MEDLINE | ID: mdl-32956678
This workshop report summarizes the proceedings of Day 1 of a three-day workshop on "Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls". Physiologically based biopharmaceutics models (PBBM) are tools which enable the drug product quality attributes to be linked to the in vivo performance. These tools rely on key quality inputs in order to provide reliable predictions. After introducing the objectives of the workshop and the expectations from the breakout sessions, Day 1 of the workshop focused on the best practices and challenges in measuring in vitro inputs needed for modeling, such as the drug solubility, the dissolution rate of the drug product, potential precipitation of the drug and drug permeability. This paper reports the podium presentations and summarizes breakout session discussions related to A) the best strategies for determining solubility, supersaturation and critical supersaturation; B) the best strategies for the development of biopredictive (clinically relevant) dissolution methods; C) the challenges associated with describing gastro-intestinal systems parameters such as mucus, liquid volume and motility; and D) the challenges with translating biopharmaceutical measures of drug permeability along the gastrointestinal tract to a meaningful model parameter.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Informe de Investigación / Modelos Biológicos Tipo de estudio: Guideline / Prognostic_studies Idioma: En Revista: J Pharm Sci Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Imprimir
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Informe de Investigación / Modelos Biológicos Tipo de estudio: Guideline / Prognostic_studies Idioma: En Revista: J Pharm Sci Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos