AC 2005 Vol-1.pdf - Cecmed - Infomed
AC 2005 Vol-1.pdf - Cecmed - Infomed
AC 2005 Vol-1.pdf - Cecmed - Infomed
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125 Trabajo experimental<br />
CIGB vs CECMED<br />
1.5<br />
1<br />
0.5<br />
0<br />
-0.5<br />
-1<br />
-1.5<br />
-2<br />
-2.5<br />
-3<br />
-2 -1 0 1 2<br />
y = 1.3572x - 0.3864<br />
R 2 = 0.9204<br />
Ln(relative<br />
potencies)<br />
Fig. 1. Correlation with the manufacturer's method. The left point represent a sample treated to high<br />
temperatures for decreasing its relative potency. The rest of samples have acceptable relative potencies.<br />
ED50<br />
150<br />
100<br />
50<br />
0<br />
-50<br />
Control Chart<br />
1<br />
3<br />
5<br />
7<br />
9<br />
11<br />
13<br />
15<br />
assay<br />
ED 50 values<br />
Mean<br />
Higher limit<br />
Lower limit<br />
Higher alarm limit<br />
Lower alarm limit<br />
Mean+SD<br />
Mean-SD<br />
Fig. 2. Control Chart for Hepatitis B vaccine standard (in vitro test). The Regional Standard for Hepatitis B<br />
vaccine was used and monitored in our lab only during the validation of the in vitro potency test for this<br />
vaccine.
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