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GUIDELINES FOR BIOAVAILABILITY & BIOEQUIVALENCE STUDIES

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 approaches in determining bioavailability and bioequivalence?
Possible methods for assessing bioavailability include determining drug liberation and dissolution at the administration or absorption site, determining free drug in systemic circulation, measuring pharmacologic effect or clinical response, and determining urinary excretion of the drug.
How bioavailability and bioequivalence studies are conducted?
Evaluation of bioavailability and bioequivalence studies will be based upon the measurement of concentrations of the active drug substances in the plasma with respective of time.
In some situations, the measurements of an active or inactive metabolite may be necessary.
The FDA considers two products bioequivalent if the 90% CI of the relative mean Cmax, AUC₍₀_-_t₎ and AUC₍₀_-_∞₎ of the test (e.g. generic formulation) to reference (e.g. innovator brand formulation) should be within 80.00% to 125.00% in the fasting state.

WHO guidelines for bioequivalence studies?