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Theophylline ER 450 mg study design [Design Issues]

posted by Ramesh Ramalingam - India, 2018-10-18 07:16  - Posting: # 19463
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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

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