Kelen
☆    

Brazil,
2023-10-04 18:31
(588 d 13:41 ago)

Posting: # 23739
Views: 3,196
 

 Application and test region of vasoconstrictor assay [Regulatives / Guidelines]

About vasoconstrictor assay, for products containing corticosteroids that are used in combination with other drugs to treat phimosis, considering the difference between the skins to be used in the vasoconstriction study and the skin that will be treated with the product, can we still consider the vasoconstrictor assay valid for this type of formulation?
dshah
★★  

India,
2023-10-17 11:34
(575 d 20:38 ago)

@ Kelen
Posting: # 23761
Views: 2,376
 

 Application and test region of vasoconstrictor assay

HI Kelen!
I am not familiar with this but Article: A Novel Approach to Assess the Potency of Topical Corticosteroids might be helpful to you.

The main question can be when using in combination with multiple product, weather the effect is due to the interest IMP or is synergistic effect?
Might be a CC with agency can be useful.

Regards,
Divyen
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