Equivalentie: in vitro en in vivo bio-equivalentie

Equivalence involves comparing drug products based on specific characteristics, functions, or a set of predefined standards. Equivalence can be of multiple types.

For example, chemical equivalence refers to two or more drug products containing equal quantities of identical active ingredients, while pharmaceutical equivalence implies sharing uniform strength, quality, purity, and content.

Therapeutic equivalence denotes that multiple drug products with the same active ingredient can control the disease identically.

Bioequivalence studies evaluate if a new drug mirrors an approved one in terms of pharmacological effects and clinical performance.

They test whether drugs in identical dosage forms share statistically similar plasma concentration-time profiles.

In vivo study needs are assessed based on therapeutic margin, absorption characteristics, physicochemical properties, and evidence of bioavailability issues.

In vitro bioequivalence studies use comparative dissolution tests to examine the release of an active ingredient from different drug products.