Studies regarding localy acting drugs [Regulatives / Guidelines]
Dear friends
regards
i want to ask that if one wants to apply for a localy acting drug eg. Sucralfate suspension, then what studies he/she has to do to get the approval?
Studies should be of clinical end point or what, as there is no other way to get the idea about BE as these drugs are not getting absorbed systemically.
Thanks & Regards
Bhupesh
regards

i want to ask that if one wants to apply for a localy acting drug eg. Sucralfate suspension, then what studies he/she has to do to get the approval?

Studies should be of clinical end point or what, as there is no other way to get the idea about BE as these drugs are not getting absorbed systemically.
Thanks & Regards
Bhupesh
