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Reference drug product is available as 100 mg and generic equivalents
are also available as 100 mg.
FDA recommendation states that BE single dose 300 mg (3 X 100 mg)
Summary Basis of Approval of generic equivalent indicates the study
performed with 100 mg of Reference v/s 100 mg of test. "Randomized two
treatment two sequence four period crossover study [replicate design]
with a three week wash out period between dosings" Treatment consisted
of a single 100 mg dose.
Pl advise do we need to stick to FDA recommendation or we can opt the
Thanks in advance,
T. Krishna Murthy,
Sr. Team Leader,
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