Cover Story

Developing equivalence margins with the PLA 3.0 Equivalence Margin Development document

Dear Sir or Madame,

PLA 3.0 supports equivalence margin development according to the preferred method described in the US Pharmacopoeia chapter <1032>. But how exactly does the EMD document work? In this week's newsletter, we will give you an overview of the different sections of the document and how they control margin development.

From zero to margin in five steps

Configuring a first equivalence margin development process in PLA 3.0 usually consists of five easy steps.

At the beginning, you need to select the development data. These should consist of assays that were conducted under comparable conditions and that produce acceptable results.

Next, you need to select the measures of similarity for which margins should be developed. At first, don't worry about selecting too many. You can define subsets in the next step.

As the third step, you can define test strategies. A test strategy consists of a set of tests on measures of similarity. For each test, you can either use the margins that will be developed upon calculation the document, or you can manually enter predefined margins.

As a fourth (optional) step, you can mark historical assays as verification assay. You can either mark assays that are also used for developing the system, or you can add assays for verification only. For these verification assays, you can define whether the assay should pass or fail the developed test system.

Calculating the Equivalence Margins Development document will develop margins for all the measures of similarity defined in step 2 (using the data defined in step 1) and evaluate the performance of the development assays and the verification assays regarding the defined test strategies.

The last step is the visualization. This step is also optional. For each strategy, simulations can be used to create hypothetical standard & sample pairs that would still pass the test system defined by that strategy.

As usual, you can review the results of the visualization, as well as all other results, through the report generated from the document.

Would you like to know more?

The truth is, it's impossible to describe all the details of the PLA 3.0 Equivalence Margin Development document and all approaches for equivalence margin development in a single newsletter. While we will certainly illuminate specific aspects of this complex topic in future newsletters, please do not hesitate to contact support@bioassay.de if you have any questions regarding this topic.  


Best regards
Mathias von Gellhorn
Marketing Manager

Stegmann Systems GmbH, Raiffeisenstr. 2, 63110 Rodgau, Germany
Phone: +49 (6106) 77010-0, Fax: +49 (6106) 77010-190
www.stegmannsystems.com


Read the whole newsletter