Drug Target Review

JULY 6, 2023

1 Ethical concerns surrounding the use of animal studies is increasing, especially considering 90 percent of drug candidates fail in clinical trials. History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, In Britain, 2.88

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Animal Testing Drugs Clinical Trials Clinical Research 105

Drug Target Review

OCTOBER 24, 2024

Janette Thomas leads a small biotech company (Five Alarm Bio) 1 on a mission to develop drugs targeting the chronic diseases associated with ageing. The company generates valuable information from imaging analyses and various biological assays, such as the scratch assay, which examines cell migration.

Cell Based Assays 52

Cell Based Assays Science Disease Doctors 52

The Premier Consulting Blog

APRIL 3, 2024

This guideline, which compliments the ICH Q2 2 Guideline, describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the evaluation of the quality of drug substances and drug products. It is a very useful tool for drug product development. ICH Harmonised Guideline.

Pharmaceuticals 52

Pharmaceuticals Cell Based Assays Production International 52

The Pharma Data

OCTOBER 15, 2020

ASLAN003 is a highly selective and potent inhibitor of human DHODH (IC 50 = 35 nM) and has been shown to be more than 30 times more potent at inhibiting the DHODH enzyme in cell free and cell-based assays than the first generation inhibitor teriflunomide. In 2019, ASLAN completed a Phase 2 study testing ASLAN003 in AML.

Pharmaceuticals 40

Pharmaceuticals Cell Based Assays Clinical Development Treatment 40

Agency IQ

APRIL 12, 2024

For example, in describing how potency should be demonstrated for CGT products, the 2011 guidance simply stated that potency for gene therapy products is derived from “at least two biological activities for its potency: the ability to transfer a genetic sequence to a cell; and the biological effect of the expressed genetic sequence.”

Production 40

Production FDA Therapies Biochemical Assays 40

Drug Target Review

MAY 3, 2024

Another good example is really any process optimization / screening domain, whether it’s cloning screening, media formulation, drug screens, etc. Ultimately, multi-omics represents an opportunity to generate high-fidelity, richly informative datasets that are often internally orthogonal. So why doesn’t everyone do it?

Research 116

Research Science Cell Based Assays Disease 116