Bioequivalence and Bioavailability Forum

avinash ★ India, 2014-01-27 12:59 (4531 d 01:02 ago) Posting: # 12274 Views: 8,025	DBE tables for FDA submission [Regulatives / Guidelines] Post reply
	Dear Members, My question with regard to DBE tables for FDA submission studies. Under Table 9 “Reanalysis of Study Samples” Two sections are there 1) Number of samples reanalyzed 2) Number of recalculated values used after reanalysis Can any one please explain me what is the difference between these two sections? Thanks & regards, Avinash Jain

drgunasakaran1
★★

2014-01-27 19:39
(4530 d 18:23 ago)

@ avinash
Posting: # 12276
Views: 7,211

DBE tables for FDA submission

Post reply

Dear Mr Avinash,

❝ 1) Number of samples reanalyzed

All the repeated samples can be taken into account for re analyzed samples. Total number of samples repeated without any exclusion will be considered for this section.

❝ 2) Number of recalculated values used after reanalysis

Usually any anamolous value identified as repeat or pre dose sample repeat can have the option of retaining the original value after the calculation. Such cases sometimes will have the original value after repeats.These original value samples will not be taken into account for calculation of number of recalculated values used after reanalysis.

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

avinash ★ India, 2014-01-28 05:47 (4530 d 08:14 ago) (edited on 2014-01-28 10:39) @ drgunasakaran1 Posting: # 12277 Views: 7,204	DBE tables for FDA submission Post reply
	Dear Doctor, Thanks for the reply. Regards, Avinash Jain 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! [Dr_Dan]

DBE tables for FDA submission [Regulatives / Guidelines]

DBE tables for FDA submission

DBE tables for FDA submission