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Clinical trials to prove that the antibody is safe in humans could begin within three years.
Clinical trials to prove that the antibodies are safe in humans could begin within three years, a researcher estimated.
Dr. Connors said that Idec and Corixa should have designed their clinical trials to prove — not just suggest — that the drugs increased survival.
"In the absence of clinically-controlled trials to prove the efficacy of the product, we considered that the claims were misleading," said the ASA.
Instead of running costly clinical trials to prove their drugs' effectiveness, generic companies would now only have to prove "bioequivalence," that is, that their drugs contained the same key ingredients as the brand, and worked the same way.
For decades, scientists at the F.D.A. approved many radiological medical devices with minimal oversight, declaring them modest improvements over older devices and thus not needing extensive reviews or clinical trials to prove their safety and efficacy.
Similar(6)
This court gave the plaintiffs the opportunity to have a trial to prove their case.
Soon even the cynics come to love Santa, but he's on trial to prove his sanity.
Many are saying that, at the very least, Phelps should swim a time trial to prove he deserves a place.
Following Wednesday's hearing, Calantropo said: ''We'll wait for this new trial to prove that my client is innocent.
"We don't need to wait for a detailed double-blind trial to prove that children who are hungry will find it hard to concentrate," says Dimbleby.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com