Calculation

Cylinder plate assay (JP 4.02) document calculations closely follow the guidelines laid out in JP 4.02.

Tip: Standard reports let you output results in print and electronic form.

Calculation sequence

You can run calculations once you have completely set up an assay document. The results of calculations are added to and saved with the assay document.

Figure 1. Basic calculation steps performed for Cylinder plate assay (JP 4.02) documents

Response data processing (optional)

Navigation: Analysis > Response data processing

Modifies response values prior to determining the standard curve line (where applicable) and calculating potencies. You can add a variety of response data processing steps and freely define the order in which they are to be executed.

The following types of response data processing are available:

  • Adjustment (optional): Subtracts a value you specify from the response values of the assay. You can adjust by a fixed value or by the response values of an assay element. You can add as many adjustment steps as you need.

  • Normalization (optional): Divides the response values of the assay by a value you specify. You can normalize by a fixed value or by the response values of an assay element. You can add as many normalization steps as you need.

Sample potency calculation

The main purpose of assay documents is to calculate potencies of test samples compared to a reference standard.

For Cylinder plate assay (JP 4.02) documents, PLA 3.0 compares the response values of the test sample at high and low concentration to the response of the standard at high and low concentration.

This lets you closely follow the applicable guidelines laid out in the Japanese Pharmacopoeia JP 4.02.