BE-Study design recommendations from regulatory authorities [Design Issues]

posted by Essar – 2006-08-22 11:07 (7236 d 15:02 ago) – Posting: # 235
Views: 8,089

Dear All,

Greetings!

Just as we receive recommendations from Office of Generic Drugs (OGD) of US-FDA regarding which BE study design to be followed and what in-vitro dissolution criteria to be adopted, does any regulatory authority in EU provides similar recommendations?

Request you to please provide your inputs.

Regards,
Essar

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