Why do we keep 5 levels in Linearity
In Linearity, Why do we keep 5 levels or 6 levels for Assay. can we keep more or less levels like 2 points like Lower and Higher.
What do we get by keeping 5 levels. Is there any guidelines about keeping a constant number of points for Linearity?
Replies to this topic (1)
2025-12-09 14:01:16
Linearity is the test uses for proof that the Material is showing response according with Concentration.
In general, Linearity is done with 5 point Linear or 6 point Linear because the more the points the greater the Integrity.
There are multiple reasons for putting 5 point Linearity as minimum :
- 1) Statistical Integrity: that means having 5 point instead of 2 points gives us easiness and true value of Linearity and mentioning that how good the points sitting in the Linear Curve.
- 2) Verifying its Linear or Non-Linear : 2 point or 3 point Linearity may have Linear but not as straight as such. The curve may be Sigmoid or parabolic sometimes. So, by putting 5 point calibration, such deviations in the Linear curve can be nullified.
- 3) Regulatory compliance: As per Regulatory guidelines like ANVISA and ICH, there must be minimum 5 point Linearity must be done as mentioned.
- 4) Reliability: The more the points, the higher the confirmation of Linearity and gives truthness of Linear curve .
So, there will be all these reasons and additional requirement of Regulatory guidelines, we must go for 5 point Linearity as minimum requirement.
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