Incorporation of additional QC during subject sample analysis. [Bioanalytics]

posted by shreyas goswami  – India, 2024-03-12 10:22 (31 d 04:30 ago) – Posting: # 23902
Views: 608

Dear Members,

Seeking for better clarity ;-)

As stated in RDC27/2012 (ANVISA) "at least two QCs are within the range of measured concentrations." unlike other regulatory agencies where it is stated " At least two QCs should be below AVG Cmax".

How it should be evaluated during subject sample analysis for ANVISA submission studies?

Can we set pre defined criteria like....67% of total periods meet above mentioned criteria or it should be on the basis of average Cmax? :confused:

Kindly share your practice and inputs.

Shreyas Goswami.

Complete thread:

UA Flag
 Admin contact
22,980 posts in 4,821 threads, 1,657 registered users;
35 visitors (0 registered, 35 guests [including 12 identified bots]).
Forum time: 15:52 CEST (Europe/Vienna)

Never, never, never use any software!
Never, never, never trust any computer!    Detlew Labes

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