Strength selection [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2012-01-27 17:07 (5261 d 16:30 ago) – Posting: # 8009
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Dear Paresh!

❝ If reference drug having list of strength 10mg, 20mg, 40mg, and 80mg.

❝ I have developed all strength and need to conduct BE study on highest strength 80mg. But for reference can i select dose as 2x40mg=80 for BE study.

❝ Due to un availability of reference drug as 80mg.


Which regulation? In the US there is only one RLD – generally the highest strength. Was the 80mg strength discontinued? If yes, why? We need more information.

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