Results 11 to 20 of about 272,653 (310)

Alchemical Analysis of FDA Approved Drugs [PDF]

open access: yesDigital Discovery, 2023
Chemical space maps help visualize similarities within molecular sets. However, there are many different molecular similarity measures resulting in a confusing number of possible comparisons.
Markus, Orsi   +3 more
core   +4 more sources

New Halogen-Containing Drugs Approved by FDA in 2021: An Overview on Their Syntheses and Pharmaceutical Use

open access: yesMolecules, 2022
This review describes the recent Food and Drug Administration (FDA)-approved drugs (in the year 2021) containing at least one halogen atom (covalently bound).
Davide Benedetto Tiz   +5 more
doaj   +3 more sources

FDA-Approved Fluorinated Heterocyclic Drugs from 2016 to 2022 [PDF]

open access: yesInternational Journal of Molecular Sciences, 2023
The inclusion of fluorine atoms or heterocyclic moiety into drug structures represents a recurrent motif in medicinal chemistry. The combination of these two features is constantly appearing in new molecular entities with various biological activities ...
Carla Rizzo, Sara Amata, Ivana Pibiri
exaly   +3 more sources

Drugs, Devices, and the FDA: Part 1

open access: yesJACC: Basic to Translational Science, 2016
Over the last 150 years, the U.S. Food and Drug Administration (FDA) has evolved from a small division of the U.S. Patent Office to 1 of the largest consumer protection agencies in the world.
Gail A. Van Norman, MD
doaj   +2 more sources

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

open access: yesCPT: 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
doaj   +1 more source

Dose selection for biological enzyme replacement therapy indicated for inborn errors of metabolism

open access: yesClinical 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
doaj   +1 more source

Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

open access: yesCPT: 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
doaj   +1 more source

A review of new drugs approved by the food and drug administration in 2022

open access: yesJournal 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
doaj   +1 more source

Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin

open access: yesCPT: 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
doaj   +1 more source

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