bioavailability bioequivalence studies

Introduction: Bioequivalence studies are safety assessments conducted by the FDA to ensure that generic drugs have the same composition as brand-name drugs. For example, if a brand-name drug contains 100 milligrams of the active ingredient, then its generic counterpart must also contain 100 milligrams of an active ingredient. However, bioequivalence studies have been misconstrued over time as being equivalent to efficacy studies; that is, they are not. There are many myths about bioequivalence studies and how they work in tandem with other factors like country of origin and manufacturing processes. The myth that generic drugs have the same composition as brand-name drugs: Generic drugs are not the same as brand-name drugs. Generic drugs must contain the active ingredient, which is the part of the drug that makes it work. This active ingredient needs to be in the same amount and form as that used by the brand-name product. If you were to compare two products containing identically shap