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 requirement has been accepted as a threshold for bioequivalence based on the assumption that differences in the systemic exposure of the evaluated pharmaceutical alternatives or pharmaceutical equivalents smaller than 20% would not be clinically significant.
Décret n° 2-14-841 relatif à l'autorisation de mise sur le marché des
Qu'est ce que l'AMM
MODALITES D'ENREGISTREMENT DES MEDICAMENTS AU MAROC
L'accès au marché d'un médicament :
Autorisation de mise sur le marché des médicaments à usage
L'AMM et ses procédures L'AMM des anti-infectieux
Procédures d'AMM
CONCEPTS ET PARAMETRES D'EVALUATION
Biodisponibilité et bioéquivalence
