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RegisterTheophylline ER 450 mg study design [Design Issues]
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
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
Complete thread:
- Theophylline ER 450 mg study designRamesh Ramalingam 2018-10-18 07:16
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