Cell Based Assays Information Pharmacokinetics 
Drug Target Review
JULY 7, 2025
Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. 7 If successful, the findings from this pilot will inform expanded regulatory guidance and potentially lead to a broader adoption of animal-free approaches across drug categories.
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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FDA Law Blog: Drug Discovery
FEBRUARY 2, 2023
The definition goes on to list potential options for such tests: cell-based assays, organ chips and microphysiological systems, computer modeling, other nonhuman or human biology-based test methods such as bioprinting, as well as animal tests. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).
Molecular Design
MARCH 26, 2024
For example, we might examine the structure-activity relationship in a cell-based assay for consistency with the structure-activity relationship that we’ve observed in the enzyme inhibition assay. This information holds the potential to achieve a profound impact on the discovery of new and enhanced medicines.
The ChEMBL-og
APRIL 16, 2024
A significant effort has been made to correctly map the drug form of the EMA data by manually inspecting different EMA sources of information, such as the Product Information (Annex I: Summary of Product Characteristics and Annex III: Labelling and Package Leaflet) and/or Assessment Report, where available. University of Dundee: T.
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