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Dear All,
Pl clarify,
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,
Regards,
T. Krishna Murthy,
Sr. Team Leader,
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