The science behind every generic.
New to BA/BE? Here are the essentials.
What is bioavailability?
Bioavailability is the rate and extent to which the active ingredient is absorbed and becomes available at the site of action. It is usually measured by the area under the plasma concentration-time curve (AUC) and the maximum concentration (Cmax).
What makes two drugs bioequivalent?
Two pharmaceutical equivalents or alternatives are bioequivalent when their rate and extent of absorption show no significant difference at the same molar dose, under similar conditions, in a properly designed study. That is why they can be expected to have the same therapeutic effect.
Why are bioequivalence studies important?
They are how a generic proves it is therapeutically interchangeable with the innovator product. Regulators rely on them to approve generics without repeating full clinical efficacy trials.
What is the 80/125 rule?
Under current FDA guidance, two products show average bioequivalence when the 90% confidence interval of the ratio of geometric means for log-transformed AUC and Cmax falls within 80% to 125%.
Which study design is right for my product?
The most common design is a two-sequence, two-period, two-treatment crossover. Replicate designs (such as Balaam's, or three- and four-period designs) estimate intra-subject variability. Williams' designs compare three or more products.
What about highly variable drugs?
For drugs with high intra-subject variability, standard limits can call for impractically large studies. Scaled average bioequivalence widens the limits according to the observed variability, within regulatory constraints.
Have a product in the pipeline?
Let's bring it to the market together. Tell us about your product and timelines, and we'll come back with a plan and a quote.