Bioequivalence and Bioavailability Forum • Anchor Point in Ligand Bind Assay

Anchor Point in Ligand Bind Assay [Bioanalytics]

posted by ketan – India, 2012-03-13 11:27 (5215 d 00:39 ago) – Posting: # 8256
Views: 7,519

Dear All,

I am carrying out ligand bind assay where the linearity range for detection of analyte is 400 – 32000 ng/mL. where 400 is anchor point and second standard concentration (STD2) 500 is LLOQ. Regression method used is Log-Log.

I have some queries regarding inclusion/exclusion of anchor point during analysis

If calibration curve is within acceptance criteria should I include anchor point?
If any calibration standard is not within acceptance criteria I should include anchor point.
If my LLOQ (500 ng/mL, STD 2) is not within acceptance criteria and if I include anchor point and then if it is within acceptance criteria then my LLOQ for that activity or batch will change from 500 to 400 ng/mL. Is it acceptable to regulatory?

Regards,
Ketan

Complete thread:

Anchor Point in Ligand Bind Assayketan 2012-03-13 10:27
- LBA: 4/5-parameter logistic regression Helmut 2012-03-14 14:47