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Metabolism of 2023 FDA Approved Small Molecules – PART 2

Metabolite Tales Blog

Table 1: Small molecule drugs approved by the FDA in 2023 with reported involvement of phase II mechanisms In vitro : In vivo differences Incubation of the SGLT2 (sodium-glucose co-transporter-2) inhibitor bexagliflozin in human liver microsomes points to metabolism through both oxidation and glucuronidation to 6 main metabolites.

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Metabolism of 2023 FDA Approved Small Molecules – PART 1

Metabolite Tales Blog

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. References [1] 2023 Novel Small Molecule FDA Drug Approvals. Health Sci Rep. 6(10):e1610.

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Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified

Alta Sciences

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

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The rising impact of biomarkers in early clinical development

Drug Target Review

Novel mechanisms of action associated with CGTs naturally create dosing effects that apply in very different ways than with traditional small molecule pharmacotherapies. Trial design and statistical methods are also key to determining the utility and validity of biomarkers.

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A spatial approach to understanding drug dynamics using mass spectrometry imaging

Drug Target Review

Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. This article explores the principles, applications and future potential of MSI in drug development. 2024, Article ASAP.

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Chemical probes and permeability

Molecular Design

The FDH is covered in the S2010 (see Box 1 and 2) and B2013 articles and, given that the targets of small molecule drugs tend to be intracellular, I’ll direct you to the excellent Smith & Rowland perspective on intracellular and intraorgan concentrations of drugs.

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New Drug Approvals

This article incorporates text from this source, which is in the public domain. ^ “Novel Drug Approvals for 2024” U.S. Article ] Yogi A, Kashimada K: Current and future perspectives on clinical management of classic 21-hydroxylase deficiency. Food and Drug Administration (FDA) (Press release). 1 October 2024. PMC 10583973.

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