Cell Based Assays Pharmacokinetics Trials 
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. NHP-C cardiomyocytes offer a more predictive and ethical platform, especially for drugs intended to advance from animal testing to first-in-human trials.
New Drug Approvals
JUNE 5, 2025
nM) and cell based assays ( EC 50 =89 nM). nM) and cell based assays ( EC 50 =89 nM). Gamcemetinib CAS 1887069-10-4 CC-99677 , OS2IR8TV1O Molecular Weight 469.94 Gamcemetinib CAS 1887069-10-4 CC-99677 , OS2IR8TV1O Molecular Weight 469.94 Gamcemetinib is extracted from patent WO2020236636, compound 1.
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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 ). FDORA § 3209(a)(2).
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.
The ChEMBL-og
APRIL 16, 2024
The data in MOLECULE_DICTIONARY.MAX_PHASE now includes consideration of: EMA approved drugs (max_phase=4 for human drugs), USAN clinical candidate drugs (assigned as max_phase = 1 based on USAN guidance that states “Firms usually apply for a USAN when the investigational therapy is in Phase I or Phase II trials”.
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.
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