Biowaiver for lower strength [Study Per­for­mance]

posted by drgunasakaran1  – 2021-08-06 14:47 (294 d 05:17 ago) – Posting: # 22515
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Dear Mr Vishal,

» However for 2.5 mg strength we are failed to submit in vitro dissolution data.

Kindly clarify whether you failed to submit the in vitro dissolution data of 2.5mg or after in vitro testing, the 2.5mg strength does not show proportional similarity and acceptable in vitro dissolution testing.

» Is we need to Conduct in vivo BE study for 2.5 mg Strength?
» what is study condition for study either Fasting or Fed or Both fasting & Fed for 2.5 mg strength?

I hope the molecule of interest is Rivaroxaban. Kindly confirm the molecule (if possible) to provide the appropriate response for your query on requirement of fasting/fed study for 2.5 mg strength.

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

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