NUSCTX 11, Final - UC Berkeley questions and answers
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Course
UC Adv
Institution
UC Adv
Preclinical Development
6-7 years of preclinical testing
Manufacturer completes synthesis and purification of the drug and conducts animal testing
Of 5000 compounds tested, ~5 will appear promising enough for a company to file an Investigational New Drug Application
If the IND is approved...
Screening Efficacy - answer In vitro models
In vivo models
Other
Early ADME - answer In silico profiling
Develop simple analytical method
Measure membrane permeability
Plasma stability
Early toxicology - answer Off target screen
In vitro cytotoxicity
Preliminary AMES
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