FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 42 U.S.C. §

Animal Testing 64

Animal Testing Biosimilars Cell Based Assays FDA 64

DrugBank

FEBRUARY 12, 2025

This approach capitalizes on prior investments in R&D, mitigates risk by leveraging established safety and pharmacokinetic profiles, and accelerates the delivery of treatments to patients. Key techniques include high-throughput screening (HTS), cell-based assays, and animal models.

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Cell Based Assays Drugs Pharmacokinetics Disease 52

The ChEMBL-og

APRIL 16, 2024

See [link] and INN clinical candidate drugs (assigned as max_phase = 2 based on INN guidance that states “As a general guide, the development of a drug should progress up to the point of clinical trials (phase II) before an application is submitted to the INN Secretariat for name selection.” University of Dundee: T.

Clinical Trials 108

Clinical Trials FDA Cell Based Assays Compound Screening 108

Alta Sciences

SEPTEMBER 27, 2024

Featuring two scenarios that explore the complexities of bioanalysis for immunomodulators, The Altascientist offers practical considerations for ensuring accurate bioanalysis, as well as pharmacokinetic, pharmacodynamic , and safety data in clinical trials.

Clinical Trials 52

Clinical Trials Trials Pharmacokinetics Small Molecule 52