Bioequivalence and Bioavailability Forum • Niacin 1000mg ER Tablets BE study

sandeep reddy
☆

India,
2013-12-12 14:52
(4577 d 02:22 ago)

Posting: # 12046
Views: 2,906

Niacin 1000mg ER Tablets BE study [Regulatives / Guidelines]

Dear forum,

kindly suggested regarding the Niacin 1000mg ER Tablets BE study for US FDA submission.

Is it necessary to stabilize the subjects in inhouse prior to drug administration and should we use baseline correction for calculation of PK parameters as the niacin is vitamin which may present in regular dietary intake.

But the draft recommendation for BE Study of Niacin no such recommendation was mentioned can we generalize the guidance for endogenous substance to niacin also.

can anyone give the idea please

Regard's
sandeep

kvgreddy06 ☆ India, 2013-12-13 15:57 (4576 d 01:18 ago) @ sandeep reddy Posting: # 12056 Views: 2,353	Niacin 1000mg ER Tablets BE study Post reply
	❝ Is it necessary to stabilize the subjects in inhouse prior to drug administration and should we use baseline correction for calculation of PK parameters as the niacin is vitamin which may present in regular dietary intake. Dear Sandeep, as per my knowledge there is no need to stabilize prior to drug adminstration and baseline correction also. Regards. KVGR