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Vault Snack #30 – Additional Curve Fits for Plotting and Analysing Assay Data in CDD Vault

Collaborative Drug

Some of the most recent enhancements to the CDD Vault Curves add-on include the Pharmacokinetic (PK) IV and Oral curve fits. This is a favored route to dose test articles given its straightforward nature as compounds bypass first-pass metabolism and enter systemic circulation instantaneously and completely.

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The future of CNS drug development: signs of real progress

Drug Target Review

2 A raft of emerging therapeutic modalities sits at the centre of this boom, spanning advanced biologics, engineered platforms and next-generation small molecules. This protective barrier prevents more than 98 percent of small-molecule drugs and all macromolecular therapeutics 3 from accessing the brain.

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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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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.

FDA
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Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study

Alta Sciences

Altasciences was chosen by a client for an IND-enabling study of a small-molecule GLP-1 receptor agonist in canines. This presents a challenge when evaluating the test article for potential toxicological effects, since the test article is designed to produce decreased food consumption and body weight loss.

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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.