DR Tablet, Sprinkle Fasting Study [Design Issues]

posted by MGR  – India, 2014-08-06 08:44 (4341 d 18:50 ago) – Posting: # 13340
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Dear All,

Can we do a sprinkle study for a DR tablet, USFDA submission? If so could you please provide the guidelines link or so?

Please see the below link for the USFDA BE recommendation Guideline.

USFDA BE Recommendation for Doxycycline Hyclate

Check for the third study, we totally confused with this recommendation.
—
Regards,
MGR

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