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Human neuronal cells: possibilities in drug safety testing

Drug Target Review

Our approach to seizure liability screening is especially pertinent in the context of the recent FDA modernization act which allows applicants to use methods other than animal testing to establish drug safety and effectiveness. Ther Innov Regul Sci. 2019 Mar 1;55:93–100. 2019 Nov 1;8(6):784–8. 2019 Jun;78:130–41.

Drugs 111
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Raising Welfare for Lab Rodents

Codon

It may seem that if researchers are sufficiently concerned about the welfare of lab animals, the best thing to do would be to stop using animals altogether. However, a multitude of factors—from institutional inertia to a global animal-testing industry worth billions of dollars —make this outcome unlikely.

Research 113
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Everything Wrong with Mouse Studies (Kinda)

Codon

The ALS Therapy Development Institute, located just ten minutes from my home in Cambridge, once tested more than 100 potential drugs to slow ALS progression in mice, all of which had been reported to be helpful in other studies. It did not change at all between the years 1972 and 2019, despite everything I’m about to tell you.

DNA 52
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Analysis Life Sciences Thank You Congress’ asks for FDA in the budget bill: Diagnostics, drug importation, vouchers and EtO updates

Agency IQ

Further, the agency would need to make a separate table finding “at least $8,500,000,” for cosmetics regulation implementation ($7 million of that) and work on finding alternatives to animal testing ($1.5 Next: Enriched Enrollment, Randomized Withdrawal (EERW) clinical trial designs.

FDA 40