Remove Bioequivalency Remove Contamination Remove Drugs Remove Generic Drugs
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Quality by design with a focus on biosimilars

Pharmaceutical Technology

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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Jailed pharma exec fined £47m and banned from industry

pharmaphorum

The man who sent the price of lifesaving drug Daraprim (pyrimethamine) rocketing from $13.50 Until recently, Daraprim was the only drug available to treat the disease and has been the gold standard treatment for toxoplasmosis for decades. a tablet to $750 overnight has been ordered to repay $64.6m (£47m).