Specialty Dosage Drugs

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Orphan drugs achieved blockbuster status in 2011, generating over $50 billion, and have the potential to generate as much lifetime revenue as drugs used for more common health conditions, according to a report from Thomson Reuters’ IP & Science division.

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The authors discuss the analysis of the resulting data, focusing on methods for the calculation of mass median aerodynamic diameter, one of the metrics routinely used for comparative testing.

Emerging methods could provide alternative ways of producing inhalable drug particles.

ePT--the Electronic Newsletter of Pharmaceutical Technology

In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate scientific approach" during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products' labeled use periods.