Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Food and Drug Administration (FDA). Bailey J, et al. Trends in Non-Human Primate Use for Research and Testing.

Drug Research 52

Drug Research Research Animal Testing Drugs 52

FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. FDORA § 3209(a)(2).

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

DrugBank

FEBRUARY 12, 2025

The pharmaceutical industry grapples with the persistent challenge of high attrition rates and escalating costs inherent in drug development. Key techniques include high-throughput screening (HTS), cell-based assays, and animal models.

Cell Based Assays 52

Cell Based Assays Drugs Pharmacokinetics Disease 52

PerkinElmer

JANUARY 7, 2020

Successful researchers and companies master and use different technologies, making sure the interpretation of data does not suffer experimental or analytical bias and leads to better success rates and higher profitability for drug developers. By assessing residence time, failure further down the drug discovery workflow can be avoided.

Small Molecule 52

Small Molecule Cell Based Assays Drugs Drug Development 52

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

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