Testing Generic Antibiotics for Equivalence
Author Information
Author(s): Zuluaga Andres F, Agudelo Maria, Rodriguez Carlos A, Vesga Omar
Primary Institution: University of Antioquia, Medellín, Colombia
Hypothesis
Can a microbiological assay effectively determine the pharmaceutical equivalence of generic intravenous antibiotics compared to innovator products?
Conclusion
The microbiological assay is a reliable method for determining the pharmaceutical equivalence of intravenous antibiotics.
Supporting Evidence
- 21 out of 22 generic products showed no significant difference in potency compared to the innovator.
- The assay demonstrated high precision and accuracy in measuring antibiotic concentrations.
- One generic product had a significantly higher concentration of active ingredient than the innovator.
Takeaway
This study shows a way to check if generic antibiotics are just as good as the original ones by using a special test.
Methodology
A microbiological assay was used to compare the potency and concentration of 22 generic antibiotics against innovator products using statistical methods.
Limitations
The method may not account for impurities or metabolites in the drugs.
Statistical Information
P-Value
0.001
Confidence Interval
95% CI
Statistical Significance
p > 0.05
Digital Object Identifier (DOI)
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