Thursday, August 5, 2010

FDA suggests QbD for patch manufacturers

Manufacturers of drug delivery patches have received a draft guidance to improve their QbD for the residual amounts of drugs left in patches. Patches usually contain more of the drug than is needed for patients to ensure that they receive the right amount of drug. It is the excess that has caused some problems, as studies show anywhere from 10-95% of the residual drug is administered to the patient after the intended use period. This ObD will encourage Pharma companies to assess their quality throughout the entire supply chain to ensure the patches are delivering the right amount of drug correctly. For more about the guidance and the ObD, Fierce Drug Delivery has the full story.

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