BE Studies

Bioequivalence (BE) studies are most widely used methods to demonstrate therapeutic equivalence between two drug products. The use of these studies can save a lot of time and cost for the development of molecules by the pharmaceutical companies. Hence bioequivalence is important to pharmaceutical companies, contract manufacturing organizations and some institutions. A lot of regulatory attention is required for planning, designing, conducting, analyzing and reporting of these studies. The focus of the bioequivalence studies is on the release of formulation and its subsequent absorption into the systemic circulation and acts as an important element for submission of new or abbreviated drugs or its supplements to the respective regulatory authority approvals.

There are many generic products are available in the markets and it has become a public concern that these products are similar to that of innovator in terms of safety and efficacy. Therefore a valid statistical evaluation is necessary to guarantee the safety and efficacy of these products.

The office of Drugs Controller General (India) at CDSCO (HQ) FDA Bhavan, New Delhi has been reviewing applications on behalf of Pharmaceutical companies, both Manufacturers and Importers as well as CRO’s, requesting for the approval to carry out BE studies with various pharmaceutical dosage formulations on Indian subjects. The office of DCG(I) would like to ensure the demonstration of the safety and efficacy of generics against corresponding innovator drugs; to ensure they are comparable and safe for consumption by human subjects.

Bioequivalence studies are carried out to compare two medicinal products containing the same active substance. The studies provide an objective  mean to assess the possibility of alternate use of them. Two products containing same active ingredients but marketed by different licensees, should be therapeutically equivalent to one another to be considered interchangeable.

There are various test methods to assess equivalence, they are-

  • Comparative bioavailability (bioequivalence) studies, in which the active drug substance or one or more metabolites is measured in an accessible biological fluid such as plasma, blood or urine.
  • Comparative pharmacodynamic studies in humans.
  • Comparative clinical trials.
  • In-vitro dissolution tests.

The pharmaceutical companies should get approval by CDSCO before conducting any bioequivalence study first by filling Form 44 and submitting other documents.

The Ethics Committee Registration Certificate is mandatory during filling of application for conducting any bioequivalence study. The other important documents required are-

  • Protocol
  • CRF
  • ICF
  • Investigator undertaking
  • Regulatory status of drug, etc.

 

 

References

  1. Midha K.K and McKay G. Bioequivalence; Its History, Practice, and Future. AAPS J. 2009 Dec; 11(4): 664–670. Available at- http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2782076/.
  2. Approved drug products with therapeutic equivalence evaluations. 36th edition. U.S. Department of health and human services food and drug administration office of medical products and tobacco center for drug evaluation and research office of generic drugs  office of generic drug policy. 2016. Available at- http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm071436.pdf. Accessed on 10th March 2016.

 

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