Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed ...
The European Medicines Agency (EMA) has released two new draft guidelines on, respectively, the quality of oral modified release products and transdermal patches. The two draft guidance documents ...
The British Pharmacopoeia on Monday released its response to its consultation on dissolution testing and announced its plans to update its approach within its product monographs. The British ...
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