Bioequivalence Study of Generic Drugs

FDA has defined bioequivalence as “the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.”

The purpose of the equivalence study is to distinguish between two clinical conditions: prescribability and switchability.

Pharmaceutical Equivalence

If the two drugs contain the same amount of the same active ingredient, which have the same dosage form and meet the same or comparable quality standards, they can be considered to be pharmaceutically equivalent.  Pharmacy equivalents do not necessarily mean bioequivalence because differences in the excipient or differences in the production process may result in a drug dissolution or absorption rate change.

Therapeutic Equivalence

If the two formulations contain the same active ingredient and are clinically shown to have the same safety and efficacy, the two drugs may be considered to have therapeutic equivalence.  If the excipients used in the two formulations do not in themselves lead to effectiveness and safety problems, bioequivalence studies are the most appropriate way to confirm the equivalence of the two formulations.  If the rate of drug absorption and clinical efficacy has nothing to do, the same degree of absorption but different rates of absorption of drugs may also achieve the equivalent of treatment.  Also in the same active ingredient, the active ingredient in different chemical forms (such as a compound of salt, ester, etc.) or dosage forms (such as tablets and capsules) drugs may also have treatment equivalence.

Essentially Similar Product

If the two formulations have the same amount and meet the same quality standard of the active ingredient, have the same dosage form and have proven to be bioequivalent, the two formulations can be considered essentially the same drug. Broadly speaking, this concept also applies to different dosage forms containing the same active ingredient, such as tablets and capsules. And the original drug is basically the same drugs should be used instead of original drugs.

Bioequivalence research studies are including pharmacokinetic study methods, pharmacodynamics research methods, RCT and in vitro methods.

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