BE study with two different batches of the reference product [Study As­sess­ment]

posted by tarak_desai – India, 2014-12-16 07:51 (3390 d 19:31 ago) – Posting: # 14076
Views: 8,967

Hello to all,

Need your guidance on following case.

In a two period, single dose, cross over, BE study, it was observd that after completion of period-I, there was insufficient quantity of the reference product available to dose subjects in period-II. sponsor also doesnt have same batch reference product availalbe with them.

can we use the different batch reference product in priod-II?
and what other measures to be taken in this case?
or redosing to be done using same batch in period-I and II or do we need to cancel study?

pls guide.

thanks.
tarak


Edit: Category changed. [Helmut]

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