ioanam ★ Romania, 2014-10-01 21:26 (3466 d 16:23 ago) Posting: # 13636 Views: 4,967 |
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Dear all, please help me with your experience in BE study for topical products (skin blanching assay). I have to plan the "staggered application and synchronized removal" using the following data: - 12 subjects - 4 treated sites/arm - 7 points (minutes / hours) for product application. The application must be performed in duplicate. 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? Thank you very much. Jo |
ClinResBE ☆ India, 2014-10-03 17:38 (3464 d 20:11 ago) @ ioanam Posting: # 13647 Views: 4,239 |
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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 |
ioanam ★ Romania, 2014-10-08 22:01 (3459 d 15:48 ago) @ ClinResBE Posting: # 13670 Views: 4,029 |
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Thank you Max. this helped me a lot. I was a little bit confused about the methodology of duplicate. Do I have to calculate an average of readings from the sites in duplicate (for the same moment) and use it in the analysis? Thank you. Ioana Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
ClinResBE ☆ India, 2014-10-10 19:26 (3457 d 18:23 ago) @ ioanam Posting: # 13686 Views: 3,949 |
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Dear Ioana, ❝ Do I have to calculate an average of readings from the sites in duplicate (for the same moment) and use it in the analysis? Pilot dose duration response study At least eight dose durations and four untreated control sites are randomly assigned among the 12 sites in each subject, maintaining two untreated control sites and four dosed sites on each arm (six sites per arm). In case more sites are dosed (duplicating of doses in the other arm) (ex: a total of 12 sites in each arm with 2 untreated sites in each arm) the averaging of AUEC values for the duplicate dose duration sites will be done. AUECs for all the individual sites will be calculated after baseline and untreated site corrections. curve will be plotted and ED50 calculated. Using ED50 the D1, D2 will be calculated. Pivotal study AUECs for the individual sites will be calculated after baseline and untreated site corrections. Averaging of duplicate sites will be done folowing which subjects' data will be selected if they meet the criteria D1 & D2 both being negative and Ratio (D2/D1)>=1.25 (Detectors) The data of these subjects will be subjected for T/R ratio calculation using Locke's method. Please check appendix III & IV in the following link for specific details http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070234.pdf Best wishes Max |
ioanam ★ Romania, 2014-10-15 12:03 (3453 d 01:46 ago) @ ClinResBE Posting: # 13711 Views: 3,841 |
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Dear Max Thank you very much! "the averaging of AUEC values for the duplicate dose duration sites will be done." is what I needed to know. Regards Ioana Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |