| Autor: |
Yamazaki, Ryuzaburo, Yamada, Masayuki, Kobayashi, Kazuo, Kitani, Shin-ichi, Shimada, Chiaki, Shimosato, Takashi, Mori, Tatsuya, Suganami, Hideki, Yamamoto, Keiji |
| Zdroj: |
Journal of Pharmacological Sciences; January 2005, Vol. 99 Issue: 5 p439-447, 9p |
| Abstrakt: |
Sixteen pharmaceutical companies and 6 contract research organizations in QT PRODACT acquired data on the action potentials in isolated guinea-pig papillary muscles using a standard protocol established by the QT PRODACT. Inter- and intra-facility variability for each of the parameters in the pre-application values and Δ% change after vehicle (0.1% DMSO) or dl-sotalol (30 μmol/L) treatment were examined using a nested model. Inter-facility variability of each of the parameters in the pre-application values were Vmax> APDs = APD30–90> APA = RMP (descending order). The inter-facility variability of all of the parameters was almost the same or was less as compared with the intra-facility variability. Inter-facility variability for the Δ% change for each parameter after dl-sotalol treatment showed a tendency similar to the results for the pre-application values. Comparing the inter- and the intra-facility variability, the interfacility variation did not exceed the intra-facility variation. All facilities found that dl-sotalol prolonged APD. Therefore, it is suggested that the test system using this standard protocol is useful as a non-clinical evaluation system for QT prolongation. Moreover, the results are considered to be directly comparable between multiple facilities. |
| Databáze: |
Supplemental Index |
| Externí odkaz: |
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