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Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report.
Pepin, Xavier J H; Parrott, Neil; Dressman, Jennifer; Delvadia, Poonam; Mitra, Amitava; Zhang, Xinyuan; Babiskin, Andrew; Kolhatkar, Vidula; Suarez-Sharp, Sandra.
Afiliación
  • Pepin XJH; New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.
  • Parrott N; Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Grenzacherstrasse 124, CH-4070 Basel, Switzerland.
  • Dressman J; Goethe University and Fraunhofer IME-TMP, Frankfurt, Germany.
  • 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 Development, Sandoz Inc (A Novartis Division), Princeton, NJ, 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.
  • Suarez-Sharp S; 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. Electronic address: Sandra.Suarez@simulations-plus.com.
J Pharm Sci ; 110(2): 555-566, 2021 02.
Article en En | MEDLINE | ID: mdl-32380182
The implementation of clinically relevant drug product specifications (CRDPS) depends on establishing a link between in vitro performance and in vivo exposure. The scientific community, including regulatory agencies, relies on biopharmaceutics tools on the in vitro performance side, while to enable the link to in vivo exposure, physiologically based pharmacokinetic (PBPK) modeling offers much promise. However, when it comes to PBPK applications in support of CRDPS, otherwise called physiologically based biopharmaceutics models (PBBM), the tools are not yet at the desired level. Currently, it is not possible to integrate detailed variations in chemistry, manufacturing and controls (CMC) attributes and parameters into these models in a way that can consistently predict their effect on local and systemic drug exposure. Specifically, to achieve the desired level, there is a need to advance the science and policy of PBBM. This manuscript summarizes the proceedings of a three-day workshop where the following themes were discussed: 1) Challenges in the development and implementation of in vitro biopredictive tools needed for successful mechanistic modeling; 2) Best practices in model development, verification and validation; and 3) Appropriate terminology (e.g., PBBM vs. PBPK models for biopharmaceutics applications) and applications of PBBM in support of drug product quality.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Informe de Investigación 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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Informe de Investigación Tipo de estudio: Guideline / Prognostic_studies Idioma: En Revista: J Pharm Sci Año: 2021 Tipo del documento: Article Pais de publicación: Estados Unidos