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Data analysis
Analytical methods, comprehensive analysis, assay workflows, and statistical process control.
Biological Assay Package
Use the Biological Assay Package for potency analysis of biological assays. The add-on comes equipped with a highly flexible test system to qualify your assay. You can perform combination calculations to obtain the reportable value from independent assay runs and use historic assay data to develop equivalence margins.
Test system definition
Use Test system definition documents to define a collection of suitability tests and corresponding margins for quantitative response assays.
Assay and sample suitability tests
Find details on the assay and sample suitability tests available for the Quantitative response assay document type.
Test: Potency range (%)
Add one or several tests for the relative-potency range to your assay.

Get started
Overview of the PLA 3.0 software, its ongoing improvements and version updates, and the available trial options.
Key concepts
Structural foundation for daily work and support for method development from initial design to routine production.
Data analysis
Analytical methods, comprehensive analysis, assay workflows, and statistical process control.
- Biological Assay Package
  Use the Biological Assay Package for potency analysis of biological assays. The add-on comes equipped with a highly flexible test system to qualify your assay. You can perform combination calculations to obtain the reportable value from independent assay runs and use historic assay data to develop equivalence margins.
  - Installation
    Find details on the system requirements for the Biological Assay Package add-on and the steps to install the add-on in your environment.
  - Basic bioassay protocol
    Use Basic bioassay protocol documents to set up a workflow for producing reportable values from multiple independent assay runs. Organize complex methods, retest scenarios, and report several products in a single assay.
  - Combination of assay results
    Use Combination of assay results documents to perform combination calculations for independent assay runs, thus obtaining reportable values for the potency.
  - Equivalence margin development
    Use Equivalence margin development documents to develop and verify test systems based on historic assays and apply these test systems in new development of quantitative response assays.
  - Quantitative response assays
    Use Quantitative response assay documents to calculate the potencies of test samples relative to an established standard. You can also use them to determine absolute potencies based on stock solutions or raw materials.
  - Test system definition
    Use Test system definition documents to define a collection of suitability tests and corresponding margins for quantitative response assays.
    - Assay and sample suitability tests
      Find details on the assay and sample suitability tests available for the Quantitative response assay document type.
      - Equivalence test: Difference of parameter estimates
        Add one or several equivalence tests for the difference of the Test or Control sample parameter minus the Standard sample parameter to your assay.
      - Equivalence test: Parameter estimate
        Add one or several equivalence tests for single parameters to your assay.
      - Equivalence test: Ratio of parameter estimates
        Add one or several equivalence tests for the ratio of the Test or Control sample parameter over the Standard sample parameter to your assay.
      - Equivalence test: Scaled parameter range
        Add one or several equivalence tests for the scaled range of the Test or Control sample parameter to the Standard sample parameter (divided by the scaling parameter) to your assay.
      - F-test (hypothesis test)
        Add one or several F-tests to your assay.
      - Point estimate test: Difference of parameter estimates
        Add one or several tests for the difference of the Test or Control sample parameter minus the Standard sample parameter to your assay.
      - Point estimate test: Parameter estimate
        Add one or several tests for single parameters to your assay.
      - Point estimate test: Ratio of parameter estimates
        Add one or several tests for the ratio of the Test or Control sample parameter over the Standard sample parameter to your assay.
      - Test: Log potency range (L-value)
        Add one or several tests for the range of the logarithmized potency to your assay.
      - Test: Maximal number of outliers
        Add one or several tests for the maximal number of outliers to your assay.
      - Test: Maximal sequence step CV (%)
        Add one or several tests for the maximal percentual coefficient of variation (CV) of sequence steps to your assay.
      - Test: Minimal R²
        Add one or several tests for the minimal R² to your assay.
      - Test: Normalized difference of asymptotes
        Add one or several tests for the normalized difference of asymptotes to your assay.
      - Test: Potency confidence interval
        Add one or several tests for the potency confidence interval to your assay.
      - Test: Potency confidence interval (%)
        Add one or several tests for the percentual potency confidence interval to your assay.
      - Test: Potency of intermediate dilution
        Add one or several tests for the intermediate dilution potency to your assay.
      - Test: Potency range (%)
        Add one or several tests for the relative-potency range to your assay.
      - Test: Potency value
        Add one or several tests for the potency value to your assay.
      - Test: Ratio sum of squares non-linearity / sum of squares regression
        Add one or several tests for the ratio of sum of squares non-linearity (sum-of-squares lack of fit) to sum of squares regression to your assay.
      - Test: Relative LOF error (%)
        Add one or several tests for the relative lack-of-fit error to your assay.
      - Test: Response value range
        Add one or several tests for the response value range to your assay.
      - Test: Root mean square error (RMSE)
        Add one or several tests for the root mean square error to your assay.
      - Test: Sum of squares non-linearity
        Add one or several tests for the sum of squares non-linearity (also known as sum of squares lack of fit) to your assay.
      - Test: Sum of squares non-parallelism
        Add one or several tests for the sum of squares non-parallelism to your assay.
      - Test: Sum of squares regression
        Add one or several tests for the sum of squares regression to your assay.
      - Test: Weight (W)
        Add one or several tests for the weight to your assay.
    - Document suitability tests
      Find details on the document suitability tests available for the Quantitative response assay document type.
  - Use case: Automate a bioassay workflow
    For some biological assays, determining relative potency within a single run is not sufficient. In these cases, you perform multiple individual assay runs and then combine the resulting data to obtain a more reliable final potency estimate. The challenge is to combine these individual results efficiently and reproducibly, particularly in regulated environments or when preparing for automated workflows.
  - Reference information
    Find reference information on the document types of the Biological Assay Package add-on.
- bioMérieux Endotoxin Detection Assay Package
  Use the bioMérieux Endotoxin Detection Assay Package add-on to perform endotoxin testing based on recombinant factor C (rFC), a synthetic alternative to naturally sourced reagents derived from horseshoe crabs, as offered by the bioMérieux company.
- Control Chart Package
  The Control Chart Package allows sophisticated statistical process control (for example, by plotting Shewhart I-Charts as recommended in the USP <1010>). It provides visualization options for intervals, subcharts and sidecharts, and allows you to define colors by a secondary characteristic. You can also define rules based on events and time frames.
- Dichotomous Assay Package
  Use the Dichotomous Assay Package to analyze biological assays based on quantal (binary) responses by fitting probit or logit models to estimate the potency of your samples.
- Dose-Response Analysis Package
  The Dose-Response Analysis Package provides various biostatistical methods for immunoassays, ELISA, and more. It supports you in investigating equivalence for calibration curves, provides enhanced data processing, and options for subgroup analysis.
- Microbial Assays for Antibiotics Package
  The Microbial Assays for Antibiotics Package for PLA 3.0 is your software for assessing the potency of antibiotics. This add-on supports various methods, that is, cylinder-plate, turbidimetric, and combination of microbial assays. It enables you to closely follow the guidelines laid out in the United States Pharmacopeia (USP <81>) and the Japanese Pharmacopoeia (JP 4.02).
- Supporting add-ons
  Find details on add-ons that support and supplement data analysis add-ons.
Data import
Import of external response values and observation data into PLA 3.0 for further processing and evaluation.
User interface
The user interface of PLA 3.0 includes graphical and textual elements designed for daily workflows.
Installation and update
Deployment, installation, and update of PLA 3.0, including initial and advanced setup.
Licensing
The licensing solution of PLA 3.0, available licensing options, and the activation and management of licenses.
Administration
Setup and maintenance of databases and add-ons, user accounts, access rights, and migration and update procedures.
Regulatory compliance
PLA 3.0 supports users in achieving compliance with regulations such as ISPE GAMP^® 5 and 21 CFR Part 11.
Glossary
Definitions of central terminology used in PLA 3.0.

Test: Potency range (%)

Add one or several tests for the relative-potency range to your assay.

Overview

To add the tests as assay suitability tests, add them as children of the Assay suitability tests element. To add the tests as sample suitability tests, add them as children of the Sample suitability tests element.

Important:

Test definitions are ignored without notification if you select a type of test that is not valid for the model you use or the scope you select.

To pass the test, the percentual relative-potency range has to be less than or equal to the upper margin set in the test definition.

Supported models

Linear parallel-line, 4-parameter logistic, 5-parameter logistic, 3-parameter logistic with fixed lower asymptote, 3-parameter logistic with fixed upper asymptote, Slope ratio

Assay elements

Test, Control