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All about Bioequivalence study


Bioequivalence is a medical term. It comes under the context of pharmacology. Further under the Pharmacology, subsystem called as pharmacokinetics. Pharmacokinetics deals with the of drugs within the body. Bioequivalence study refers to the similarity of two drugs. They will share the properties of this same outcome. So when you call two medicines to be bioequivalent they will have the same effect.

So bioequivalence study is finding out the similarity of two drugs. The study further reveals that bioequivalence drugs will release the same ingredient in the bloodstream. More precisely, one ingredient will be released in the same amount and at the same time.

World Health Organisation and Bioequivalence study

According to the World Health Organisation, any two Pharmaceutical products are bioequivalent if the Pharmaceutical alternatives. The rate, the molar dosage, the level of absorption all will lead to the identification of bioequivalence between drugs.

Significance and Standards

Bioequivalence study will be conducted to determine by comparing the commercially available product to the market generic version. This will allow us to know the core attributes that is shared by these two drugs. There are different bioequivalence standards. This will differ on whether it is a pill, injection, inhaler, etc.

Bioequivalence and Bioavailability

Bioequivalence is a concept that is based on bioavailability. It helps to establish the equivalence between any two drugs. The same drug is made available by different manufacturers in different forms and under different brand names. For example, the same medicine is made available in 10 different establishment forms capsule forms and 10 different injections as well. So there is a need to equate these different brands. Bioequivalence study helps us in determining the same effects of different drugs.

Bioavailability is the measurement of therapeutically active medicine. It is the one which reaches the systemic circulation.

How bioequivalence is determined?

Bioequivalence is determined by developing various bioequivalencies. It includes the following.

  • Chemical equivalence
  • Bioequivalence
  • Pharmaceutical equivalence
  • Therapeutic equivalence

Chemical equivalence – It is based upon the content and the quantity of the content of the two drugs. Thus, equivalence means the usage of the same content in any two drugs in any form.

Pharmaceutical equivalence – It means that Pharmaceutically two drugs are equivalent. When two drugs are pharmaceutically equivalent, they are same in the content in the quantity and also in the dosage.

Bioequivalence – Bioequivalence occurs when two drugs are biological equivalence. This is determined when the Pharmaceutical equivalent when administered into a biological body produces the same level of Plasma concentration profile or when the bioavailability is the same it is called to be bioequivalence.

Therapeutic equivalence – It is determined through the usage of any two drugs and analyzing the aftereffect of drugs.


Government responsibility

It is very important for any government of any nation to conduct the bioequivalence study to reduce the drug debris. Recently, many of the companies were identified which were illegally making use of the bioequivalence. A huge amount of fine was also slammed on them to discourage the action.