Establishment of alternative potency test for botulinum toxin type A using compound muscle action potential (CMAP) in rats.

In this study, to evaluate this quantitative method of measuring toxin activity using CMAP, we assessed the parameters necessary for quantitative tests according to ICH Q2 (R1). This assay could be used to evaluate the activity of the toxin, even when inactive toxin was mixed with the sample. To reduce the number of animals needed, this assay was set to measure two samples per animal. Linearity was detected over a range of 0.1∼12.8 U/mL, and the measurement range was set at 0.4∼6.4 U/mL. The results for accuracy and precision showed low variability. The body weight was selected as a variable factor, but it showed no effect on the CMAP amplitude. In this study, potency tests using the rat CMAP assay of botulinum toxin type A demonstrated that it met the criteria for a quantitative analysis method.
PMID: 25110177 [PubMed - as supplied by publisher]

Source: Toxicon - August 7, 2014 Category: Toxicology Authors: Torii Y, Goto Y, Nakahira S, Ginnaga A Tags: Toxicon Source Type: research