Drug Target Review

JULY 6, 2023

History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, 3 The first act was approved in 1938 in response to a drug — elixir sulphanilamide — that caused 105 deaths after researchers failed to test the antibiotic before release.

Animal Testing 105

Animal Testing Drugs Clinical Trials Clinical Research 105

Elrig

APRIL 29, 2024

Inspired by her time at GSK, Millie pursued a PhD at the University of Cambridge investigating the signalling pathways that drive cancer cell growth using in-vitro cell based assays and biochemical analysis. Driven by an interest in drug discovery Millie joined AstraZeneca after completion of her PhD at the end of 2020.

Bioinformatics 59

Bioinformatics Drugs Molecular Biology Cell Based Assays 59

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