Bioequivalence and Bioavailability Forum

staggered application and synchronized removal [Design Issues]

posted by ClinResBE – India, 2014-10-03 17:38 (4288 d 14:38 ago) – Posting: # 13647
Views: 5,745

Hi Jo,

❝ The question is: how do I have to allocate the moment of application for the treated sites for one subject and / or for all subjects?

The sites will be randomized for both arms and dosing will be done for all subjects.

Please find the images that should clarify the order of treatment (staggered application & synchrovized removal) for dose duration response study and pivotal studies. This is as recommended by the guidance document 'GUIDANCE TOPICAL DERMATOLOGIC CORTICOSTEROIDS:IN VIVO BIOEQUIVALENCE'





I hope this will help you.

Max

Complete thread:

• staggered application and synchronized removal ioanam 2014-10-01 19:26 
  • staggered application and synchronized removalClinResBE 2014-10-03 15:38
    • staggered application and synchronized removal ioanam 2014-10-08 20:01
      • staggered application and synchronized removal ClinResBE 2014-10-10 17:26
        • staggered application and synchronized removal ioanam 2014-10-15 10:03