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Mahesh M ★ India, 2014-02-13 08:09 (4517 d 15:01 ago) Posting: # 12414 Views: 6,082 |
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Can anybody suggest about diclofenac sodium gel 1 % bioequivalence study design ? Regards Mahesh |
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Dr_Dan ★★ Germany, 2014-02-13 18:28 (4517 d 04:42 ago) @ Mahesh M Posting: # 12418 Views: 4,943 |
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Dear Mahesh In general bioequivalence studies are conducted in case of oral dosage forms with systemic action. I guess in your case you are investigating a product for local application and local action, right? For further information please see this link. I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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Mahesh M ★ India, 2014-02-14 08:58 (4516 d 14:12 ago) @ Dr_Dan Posting: # 12421 Views: 5,050 |
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Dear Dr. Dan, Thanks for your prompt response but Draft Guidance on Diclofenac Sodium by USFDA says that "Single-dose, two-way crossover in vivo" problem is that there is no data available for single dose (Topical application)of Cmax and AUC. In SBOA they did steady state study. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM296889.pdf Regards Mahesh |
Ing. Helmut Schütz