Astm D7386 ✔

This is the most critical aspect of D7386. The FDA and EMA allow manufacturers to skip bioequivalence studies (clinical trials comparing the generic to the brand name) for BCS Class I/III drugs if they can prove the drug dissolves rapidly. This is called a .

D7386 Standard Practice for Performance Testing of ... - ASTM astm d7386

: Requires tests to be performed in a specific order to replicate the cumulative stress of a delivery cycle. The Core Testing Sequences This is the most critical aspect of D7386