Design the generic ophthalmic solutions clinical trials [Design Issues]

posted by ElMaestro  – Denmark, 2012-01-20 09:31 (5266 d 00:29 ago) – Posting: # 7971
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Hi Gore,

All the ophthalmic solutions come in the bottle, which are produced with the specific chemical ingredients, colours and dimension with shape.


In such cases if we are the generic developer how to conduct clinical trial and it’s blinding when the competitor ophthalmic preparation available in the patented bottle only?


How about double dummies? You take the originator's bottle, empty it and fill it with placebo. Each patient then gets X drops from the generic (verum or placebo) and X drops from the originator (verum or placebo) per period.

Best regards,
EM.

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