Determine the potency of antibiotics

The Microbial Assays for Antibiotics Package (available as a free add-on) covers potency estimation of cylinder-plate assays and turbidimetric assays as described in the U.S. Pharmacopeia <81> and Japanese Pharmacopoeia Chapter 4.02. It also allows to group samples and aggregate samples of independent assay runs to calculate combined potencies. For cylinder-plate assays, inter-plate variation correction methods are provided as recommended in USP <81>. Moreover, logarithmic dose transformation and response data processing can be applied. The customizable documentation section includes additional information for documentary purposes such as antibiotic description, inoculum preparation, and assay setup. Finally, the validity of the assay can be proven in configurable tests on the calculated parameters.

• Calculate potencies based on the cylinder-plate and turbidimetric method.
• Perform the assays by following the U.S. Pharmacopeia <81> or the Japanese Pharmacopoeia Chapter 4.02.
• Document the entire procedure of inoculum preparation and assay setup.
• Configure dose transformation and response data processing.
• Set up combination groups to estimate the combined potency within a group of samples.
• Define a test system to account for the calculated variables.

The Microbial Assays for Antibiotics Package provides you with document types for the cylinder-plate and turbidimetric method to estimate the potency of your test samples following either the U.S. Pharmacopeia (USP) <81> or the Japanese Pharmacopoeia (JP) Chapter 4.02. You can aggregate independent assay runs into the combination of microbial assays document for combined potency calculation. For documentary purposes, you can enter information about the antibiotic, inoculum preparation, and assay setup into the documentation section of the individual assay documents. Moreover, prove the validity of the assay in your test system by accounting for parameters such as the correction point (USP <81>) or the potency factor A (JP Chapter 4.02).

The Microbial Assays for Antibiotics Package follows the guidances of the U.S. Pharmacopeia (USP) <81> and Japanese Pharmacopoeia (JP) Chapter 4.02 in separate document types to estimate the potency of cylinder-plate and turbidimetric assays.* It supports you during preparation of the assay by providing customizable documentation options regarding the antibiotic and the inoculum. For instance, information about the incubation, the base and seed layer medium, the equipment, the operator, and the purpose can be recorded. In addition, when performing a cylinder-plate assay as described in the USP <81>, you can apply plate-to-plate variation correction choosing between the correction point method and estimations from the regression line. Next, you can define test systems to prove the validity of your assay. Finally, the results provide you with potency estimations for your test samples including overall test results. Once you have collected data from multiple assay runs, aggregate the independent documents to perform combined potency calculations for each combination group of test samples.

^{*Set up microbial assays for antibiotics according to regulations by the European Pharmacopoeia with Quantitative response assay documents from the Biological Assay Package.}