DBE tables for FDA submission [Regulatives / Guidelines]

posted by drgunasakaran1  – 2014-01-27 19:39 (4534 d 12:23 ago) – Posting: # 12276
Views: 7,226

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

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,572 registered users;
367 visitors (0 registered, 367 guests [including 19 identified bots]).
Forum time: 09:02 CEST (Europe/Vienna)

The real struggle is not between the right and the left
but between the party of the thoughtful
and the party of the jerks.    Jimmy Wales

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5