^{PDFprof.com Search Engine}

Guideline o the Investigation of Bioequivalence

WHO guidelines for bioequivalence studies?
Multisource (generic) products must satisfy the same standards as those applied to originator products.
The manufacturer of a multisource (generic product) must demonstrate that its product: satisfies the same standards as those applicable to the innovator product.
What are the rules for bioequivalence?
Products are considered to be bioequivalent, if the 90% confidence interval of difference in the average values of logarithmic parameters to be assessed between test and reference products is within the acceptable range of log(0.80) - log(1.25).
What are the methods of determining bioequivalence?
In bioequivalence studies, the plasma concentration time curve is generally used to assess the rate and extent of absorption.
Selected pharmacokinetic parameters and preset acceptance limits allow the final decision on bioequivalence of the tested products._{20 jan. 2010}
The 80%-125% Bioequivalence Criterion
Two pharmaceutical alternatives or pharmaceutical equivalents are considered bioequivalent if the 90% confidence intervals (CIs) of the ratios of the geometric means of the AUC and Cmax after a logarithmic transformation are within the bioequivalence limits of 80% and 125%.

WHO guidelines for bioequivalence studies?