Bioequivalence and Bioavailability Forum

Mahesh M ★ India, 2014-02-13 08:09 (4521 d 03:20 ago) Posting: # 12414 Views: 6,122	Diclofenac sodium gel 1 % [Design Issues] Post reply
	Can anybody suggest about diclofenac sodium gel 1 % bioequivalence study design ? Regards Mahesh

Dr_Dan ★★ Germany, 2014-02-13 18:28 (4520 d 17:00 ago) @ Mahesh M Posting: # 12418 Views: 4,962	Diclofenac sodium gel 1 % Post reply
	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

Mahesh M ★ India, 2014-02-14 08:58 (4520 d 02:31 ago) @ Dr_Dan Posting: # 12421 Views: 5,077	Diclofenac sodium gel 1 % Post reply
	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 Dan, Thanks for your prompt response but Draft Guidance on Diclofenac Sodium by USFDA says that "Single-dose, two-way crossover in vivo" problem is that there is no data available for single dose (Topical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

Diclofenac sodium gel 1 % [Design Issues]