Remove Cell Based Assays Remove Definition Remove Pharmacokinetics
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Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act

FDA Law Blog: Drug Discovery

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).

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Leadeth me unto Truth and delivereth me from those who have already found it

Molecular Design

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. We have to make assumptions in these situations and we also need to check that these assumptions are reasonable.

Drugs 60
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ChEMBL 34 is out!

The ChEMBL-og

The definition of a chemical probe has been amended to update the field MOLECULE_DICTIONARY.CHEMICAL_PROBE. For legacy AUC and Cmax records (< ChEMBL 34), pharmacokinetic parameters have been extracted from the assay descriptions using regular expression matching (RegEx). University of Dundee: T.