Ramesh Ramalingam ☆ India, 2018-10-18 09:16 (2009 d 00:15 ago) Posting: # 19463 Views: 2,155 |
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Dear Members, Based on literature reference, Theophylline is a narrow therapeutic index drug. As per USFDA recommendation if the drugs falls under narrow therapeutic index, the BE study should be a fully replicated crossover design in order to: • Scale bioequivalence limits to the variability of the reference product; and • Compare test and reference products within-subject variability. But respective molecule OGD (which was issued on 2010) Draft guidelines recommending two-way cross-over study design. Could you please suggest the study design whether it should be two-period, two-way crossover design or four period, fully replicated design. Regards, Ramesh |