Results 11 to 20 of about 4,829,888 (359)
CPT: Pharmacometrics & Systems Pharmacology, 2023 This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the US Food and Drug ...
Fang Wu +17 more
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Frontiers in Pharmacology, 2022 Type 2 diabetes mellitus (T2DM) continues to be a substantial medical problem due to its increasing global prevalence and because chronic hyperglycemic states are closely linked with obesity, liver disease and several cardiovascular diseases.
Amelia D. Dahlén +6 more
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Dose selection for biological enzyme replacement therapy indicated for inborn errors of metabolism
Clinical and Translational Science, 2023 This paper summarizes key features of the dose‐finding strategies used in the development of 11 approved new molecular entities that are first‐in‐class enzyme replacement therapy (ERT), with a goal to gain insight into the dose exploration approaches to ...
Yuen Yi Hon +8 more
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Journal of Hematology & Oncology, 2022 The United States Food and Drug Administration (US FDA) has always been a forerunner in drug evaluation and supervision. Over the past 31 years, 1050 drugs (excluding vaccines, cell-based therapies, and gene therapy products) have been approved as new ...
Qing Wu +3 more
semanticscholar +1 more source
CPT: Pharmacometrics & Systems Pharmacology, 2021 Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences.
Eleftheria Tsakalozou +2 more
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A review of new drugs approved by the food and drug administration in 2022
Journal of Family Medicine and Primary Care, 2023 Introduction: The drugs approved by the Food and Drug Administration (FDA) in 2022, for the first time for any indication or under any brand, were studied under the contexts of indications, mechanism of action, and side effects.
Arjun Swaminathan +2 more
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FDA-Approved Trifluoromethyl Group-Containing Drugs: A Review of 20 Years
Processes, 2022 As people around the world regard 2020 as the year of COVID-19, the medical community considers this year to be the second-best year, shared with the year 1996, with respect to the number of drug molecules approved by the US Food and Drug Administration (
Aathira S. Nair +9 more
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CPT: Pharmacometrics & Systems Pharmacology, 2022 Physiologically‐based pharmacokinetic models combine knowledge about physiology, drug product properties, such as physicochemical parameters, absorption, distribution, metabolism, excretion characteristics, formulation attributes, and trial design or ...
Nikunjkumar Patel +14 more
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Mechanistic modeling of drug products applied to the skin: A workshop summary report
CPT: Pharmacometrics & Systems Pharmacology, 2023 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.
Eleftheria Tsakalozou +9 more
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Autophagy Reports, 2022 Autophagy is a conserved intracellular degradation pathway that is essential for maintaining cellular homeostasis. Given its critical role in several disease conditions, recent studies are focussed on identifying drugs/small molecules with autophagy ...
Surendra Kumar Prajapat +4 more
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