Bioequivalence and Bioavailability Forum • Design the generic ophthalmic solutions clinical trials

gore.lalit
●

2012-01-20 06:26
(5256 d 05:23 ago)

Posting: # 7970
Views: 3,271

Design the generic ophthalmic solutions clinical trials [Design Issues]

Dear All,

I am working on one generic ophthalmic solutions clinical trial.

Please guide me or clarify few points for preparation of generic ophthalmic solutions trial samples for Clinical trials

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 to carry out clinical trial in such situation for registration with USFDA for ophthalmic preparation?

Your guidance is highly appreciated.

Please provide me suitable literature/reference articles, which will help out to carry ophthalmic solutions clinical trials

Regards

LALIT GORE
8976631566

Edit: E-mail address removed. Other users can contact you through the [image]

webform. [Helmut]

ElMaestro
★★★

Denmark,
2012-01-20 09:31
(5256 d 02:18 ago)

@ gore.lalit
Posting: # 7971
Views: 2,561

Design the generic ophthalmic solutions clinical trials

Post reply

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.