QCs per run-acceptance criteria [Bioanalytics]

posted by nilima – 2007-11-20 07:29 (6785 d 14:56 ago) – Posting: # 1307
Views: 6,609

Dear Sir

Please refer to the Bioanalytical Method Validation Guideline -May 2001

Section VI "Application of Validated Method to Routine Analysis"

QC samples in duplicate at 3 concentrations ( LQC, MQC and HQC ) should be arranged in each assay run. What is meant by run, all samples analysed in a day using same Calibration curve, secondly what is meant by duplicate ( 2xLQC, 2xMQC and 2xHQC -duplicate or replicate...?)


Thanks in advance.

Nilima Kalra

Complete thread:

UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,570 registered users;
240 visitors (0 registered, 240 guests [including 118 identified bots]).
Forum time: 23:26 CEST (Europe/Vienna)

“Data! Data! Data!” he cried impatiently.
“I can’t make bricks without clay!”    Arthur Conan Doyle

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