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The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary.
Optimising spray-dried solid dispersions to improve solubility SHARES Manufacturing drug products with low solubility APIs (BCS type II and IV) has its challenges, in this article, Javier Gurrea, a Spray Drying Manufacturing Scientist at Idifarma, explains why spray drying offers a great way to overcome them. Today’s active pharmaceutical ingredients (API) are increasingly insoluble and that can pose serious problems for formulators looking to manage bioavailability and dosing of their formulations. Moreover, the trend is building: around 40 percent of new potentially active chemical compou...