Drug Target Review

SEPTEMBER 26, 2023

This shift occurred following implementation of the Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative in 2013 and extensive testing of hiPSC-cardiomyocytes with known proarrhythmic drugs. 2018 Mar;17(3):167–81. 2018 Dec 11;94(10):390–411. 2018;(136):56573. Nat Rev Drug Discov. J Pharmacol Toxicol Methods.

Drugs 111

Drugs FDA Disease Animal Testing 111

Codon

MARCH 14, 2023

The engineered T-cells were infused back into the rodents. A few days later, though, alarms: Animals with the modified T-cells had massive spikes in their cytokine levels, a sign that their b odies were under attack, crying out for help. had already done much the same T-cell engineering on 106 patients at the National Cancer Institute.

DNA 52

DNA Laboratories Engineering Animal Testing 52

Drug & Device Law

NOVEMBER 6, 2023

Among the types of device testing addressed by the Implant Draft Guidance are: (1) “engineering analysis,” (2) “materials specifications,” (3) “finite element analysis,” (4) “bench model testing,” and (5) “animal testing,” particularly when “knowledge and refinement of surgical technique. . .

FDA 59

FDA Animal Testing Licensing Licensing 59