Design the generic ophthalmic solutions clinical trials [Design Issues]

posted by gore.lalit – 2012-01-20 06:26 (5274 d 03:10 ago) – Posting: # 7970
Views: 3,304

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]

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
252 visitors (0 registered, 252 guests [including 16 identified bots]).
Forum time: 10:37 CEST (Europe/Vienna)

Most scientists today are devoid of ideas, full of fear, intent on
producing some paltry result so that they can add to the flood
of inane papers that now constitutes “scientific progress”
in many areas.    Paul Feyerabend

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5