Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling.

Autor: Pepin XJH; Simulations Plus, Lancaster, California, USA., Hynes SM; Biogen, Inc., Cambridge, Massachusetts, USA., Zahir H; Biogen, Inc., Cambridge, Massachusetts, USA., Walker D; Reata Pharmaceuticals, Inc., Plano, Texas, USA., Semmens LQ; Biogen, Inc., Cambridge, Massachusetts, USA., Suarez-Sharp S; Simulations Plus, Lancaster, California, USA.

Publikováno v: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Oct; Vol. 13 (10), pp. 1771-1783. Date of Electronic Publication: 2024 Sep 02.

SubQ-Sim: A Subcutaneous Physiologically Based Biopharmaceutics Model. Part 1: The Injection and System Parameters.

Autor: Pepin XJH; Regulatory Affairs, Simulations Plus, Lancaster, CA, USA., Grant I; Innovation Strategy & External Liaison, Pharmaceutical Technology & Development, Operations, AstraZeneca, Charter Way, Macclesfield, SK10 2NA, UK. iain.grant@astrazeneca.com., Wood JM; New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.

Publikováno v: Pharmaceutical research [Pharm Res] 2023 Sep; Vol. 40 (9), pp. 2195-2214. Date of Electronic Publication: 2023 Aug 27.

The Use of Physiologically Based Pharmacokinetic Analyses-in Biopharmaceutics Applications -Regulatory and Industry Perspectives.

Autor: Anand O; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland, USA. Om.Anand@fda.hhs.gov., Pepin XJH; New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK., Kolhatkar V; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland, USA., Seo P; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland, USA.

Publikováno v: Pharmaceutical research [Pharm Res] 2022 Aug; Vol. 39 (8), pp. 1681-1700. Date of Electronic Publication: 2022 May 18.

Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report.

Autor: 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.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2021 Feb; Vol. 110 (2), pp. 555-566. Date of Electronic Publication: 2020 May 04.

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.

Autor: Mitra A; Clinical Pharmacology and Pharmacometrics, Janssen Research & Development, Spring House, Pennsylvania. Electronic address: amitra24@its.jnj.com., Suarez-Sharp S; Regulatory Affairs, Simulations Plus Inc., Lancaster, California., Pepin XJH; New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK., Flanagan T; Pharmaceutical Development, UCB Pharma SA, Braine l'Alleud, Belgium., Zhao Y; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland., Kotzagiorgis E; Pharmaceutical Quality Office, European Medicines Agency (EMA), Amsterdam, the Netherlands., Parrott N; Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Sharan S; 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 (FDA), Silver Spring, Maryland., Tistaert C; Pharmaceutical Sciences, Janssen Research & Development, Beerse, Belgium., Heimbach T; PK Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey., Zolnik B; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland., Sjögren E; Pharmatheus, Uppsala, Sweden., Wu F; 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 (FDA), Silver Spring, Maryland., Anand O; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland., Kakar S; PK Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey., Li M; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland., Veerasingham S; Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, Ottawa, Canada., Kijima S; Office of Advanced Evaluation with Electronic Data, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan., Lima Santos GM; General Office of Medicines and Biological Products, Brazilian Health Regulatory Agency (Anvisa), Brasilia, Brazil., Ning B; National Institutes for Food and Drug Control (NIFDC), Beijing, China., Raines K; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland., Rullo G; Regulatory Excellence, Oncology R&D, AstraZeneca, Gaithersburg, Maryland., Mandula H; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland., Delvadia P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland., Dressman J; Fraunhofer Institute for Molecular Biology and Applied Ecology, and Goethe University, Frankfurt, Germany., Dickinson PA; Seda Pharmaceutical Development Services, Alderley Park, Alderley Edge, Cheshire, UK., 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 (FDA), Silver Spring, Maryland.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2021 Feb; Vol. 110 (2), pp. 594-609. Date of Electronic Publication: 2020 Nov 03.