Analytical methods

Design potency assays, cylinder-plate and turbidimetric assays. Set up interpolation analysis, curve comparisons, and more.

The following table shows which add-on provides which analytical method:


Which method do you want to apply?	Which add-on do you need?
Curve comparisons	Dose-Response Analysis Package
Cylinder plate assays (USP <81> and JP 4.02)	Microbial Assays for Antibiotics Package
Quantal response potency assay (dichotomous potency assay)	Dichotomous Assay Package
ECx calculation	Dose-Response Analysis Package
Interpolation analysis	Dose-Response Analysis Package
bioMérieux endotoxin detection assays	bioMérieux Endotoxin Detection Assay Package
Linearity-of-dilution assessment	Dose-Response Analysis Package
Parallel-line potency assay	Biological Assay Package
Parallel logistic potency assay	Biological Assay Package
Slope-ratio potency assay	Biological Assay Package
Spike-and-recovery analysis	Dose-Response Analysis Package
Turbidimetric assay	Microbial Assays for Antibiotics Package

Supported models

PLA 3.0 includes a broad range of regression models. Each model is available through one or more document types.

The following models are available:

Linear model

The following document types support the linear regression model:


Document type	Description	Details
bioMérieux endotoxin detection assay	Interpolation analysis with a specialized handling for low signal samples, especially designed for endotoxin impurity assays.	For details, see: Linear model
Cylinder plate assay (JP 4.02)	Simple 2x2 model for cylinder plate assays according to JP 4.02.	For details, see: Cylinder plate assays (JP 4.02)
Cylinder plate assay (USP <81>)	Interpolation analysis with data processing steps specific to USP <81>.	For details, see: Cylinder plate assays (USP <81>)
Dichotomous assay	Generalized linear model for parallel-line potency assays using quantal (count) data with a probit or logit link function.	For details, see: Regression model
Dose-response analysis	Curve comparisons and interpolation analysis.	For details, see: Curve comparisons Interpolation on calibration curves Linear model
Quantitative response assay	Parallel-line potency assays.	For details, see: Parallel-line potency assays Linear parallel-line
Turbidimetric assay (USP <81>/JP 4.02)	Interpolation analysis with data processing steps specific to USP <81> and JP 4.02.	For details, see: Turbidimetric assays (USP <81>/JP 4.02)

2-parameter logistic model

The following document type supports the 2-parameter logistic regression model:


Document type	Description	Details
Dose-response analysis	Curve comparisons and interpolation analysis.	For details, see: 2-parameter logistic fit model with fixed asymptotes

3-parameter logistic model

Fixes one of the asymptotes of the 4-parameter logistic model either through manual input or a control line.

The following document types support the 3-parameter logistic regression model:


Document type	Description	Details
Quantitative response assay	Parallel-logistic potency assays.	For details, see: 3-parameter logistic fit with fixed upper asymptote 3-parameter logistic fit with fixed lower asymptote
Dose-response analysis	Curve comparison and interpolation analysis.	For details, see 3-parameter logistic fit model with fixed upper asymptote 3-parameter logistic fit model with fixed lower asymptote

4-parameter logistic model

The following document types support the 4-parameter logistic regression model:


Document type	Description	Details
bioMérieux endotoxin detection assay	Interpolation analysis with a specialized handling for low signal samples, especially designed for endotoxin impurity assays. Uses weighting.	For details, see: 4-parameter logistic model
Dose-response analysis	Curve comparison and interpolation analysis.	For details, see 4-parameter logistic fit model
Quantitative response assay	Parallel-logistic potency assays. Supports the 4-parameter logistic model with and without control line.	For details, see: Parallel-logistic potency assays 4-parameter logistic fit

5-parameter logistic model

Extends the 4-parameter logistic model by including a parameter that controls model asymmetry.

The following document types support the 5-parameter logistic regression model:


Document type	Description	Details
Quantitative response assay	Parallel-logistic potency assays.	For details, see: 5-parameter logistic fit
Dose-response analysis	Curve comparison and interpolation analysis.	For details, see: 5-parameter logistic fit model

Hill equation

The following document type supports the Hill equation regression model:


Document type	Description	Details
Dose-response analysis	Curve comparisons and interpolation analysis.	For details, see: Hill equation