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KFDA clarifies bioequivalence testing on transdermal drugs
The Korea Food and Drug Administration has unveiled its policy on the bioequivalence testing of oral transdermal medicines in a form of question and answer (Q/A).
The Q/A describes comparative disintegration test and its validation, including precipitation in the comparative disintegration.
It also includes the handling of phase separation and inhomogeneous mixing in soft capsules.
So ...
The Q/A describes comparative disintegration test and its validation, including precipitation in the comparative disintegration.
It also includes the handling of phase separation and inhomogeneous mixing in soft capsules.
So ...
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