دورية أكاديمية
أعرض في EDS

Mechanistic modeling of drug products applied to the skin: A workshop summary report.

التفاصيل البيبلوغرافية
العنوان: Mechanistic modeling of drug products applied to the skin: A workshop summary report.
المؤلفون: Tsakalozou E; Division of Quantitative Methods and Modeling, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA., Alam K; Division of Quantitative Methods and Modeling, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA., Ghosh P; Division of Therapeutic Performance I, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA., Spires J; Simulations Plus, Inc., Lancaster, California, USA., Polak S; Certara UK, Simcyp Division, Sheffield, UK.; Jagiellonian University Medical College, Krakow, Poland., Fang L; Division of Quantitative Methods and Modeling, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA., Sammeta S; Teva Pharmaceuticals, Salt Lake City, Utah, USA., Zhao P; Bill & Melinda Gates Foundation, Seattle, Washington, USA., Arora S; Certara UK, Simcyp Division, Sheffield, UK.; Janssen Pharmaceutical, Companies of Johnson & Johnson, Beerse, Belgium., Raney SG; Division of Therapeutic Performance I, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
المصدر: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2023 May; Vol. 12 (5), pp. 575-584. Date of Electronic Publication: 2022 Dec 01.
نوع المنشور: Journal Article; Review; Research Support, U.S. Gov't, P.H.S.
اللغة: English
بيانات الدورية: Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2015- : Hoboken, NJ : Wiley
Original Publication: New York, NY : Nature Pub. Group
مواضيع طبية MeSH: Drugs, Generic* , Research Report*, Humans ; Pharmaceutical Preparations ; Skin ; Therapeutic Equivalency
مستخلص: The development of a generic drug product involves demonstrating that there is no significant difference in the rate and extent to which the active ingredient becomes available at the site of action, relative to the reference listed drug product. This remains challenging for many locally acting topical dermatological products because measuring the concentration of the active ingredient at the site of action in the skin may not be straightforward, and, in most instances, there are no established relationships between skin and plasma pharmacokinetic profiles. In recent years, the Office of Generic Drugs of the US Food and Drug Administration (FDA) established scientific research programs with the goal of enhancing patient access to high quality, affordable topical dermatological generics. A key strategy of these research programs was to leverage modeling and simulation methodologies that accelerate the development of these generics by facilitating alternative bioequivalence approaches for dermatological drug products. This report summarizes relevant insights and discussions from a 2021 FDA public workshop titled "Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches," which illustrated how mechanistic modeling and simulation approaches can be utilized (and have been used) to inform generic drug product development and regulatory decisions during the assessment of generic drug applications submitted to the FDA.
(© 2022 Bill & Melinda Gates Foundation, The Authors and Simulations Plus, Inc, et al. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)
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معلومات مُعتمدة: U01 FD006526 United States FD FDA HHS
المشرفين على المادة: 0 (Drugs, Generic)
0 (Pharmaceutical Preparations)
تواريخ الأحداث: Date Created: 20221201 Date Completed: 20230522 Latest Revision: 20230523
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC10196403
DOI: 10.1002/psp4.12893
PMID: 36456539
قاعدة البيانات: MEDLINE
الوصف
تدمد:2163-8306
DOI:10.1002/psp4.12893