Background: The concept of evaluating bioequivalence has changed over a period of time. Currently, the
Average Bioequivalence approach (ABE) is the gold standard tool for the evaluation of generics. Of late, many debates
had arisen about employing ABE approach for the appraisal of all drug categories. This review aims to examine
the limitations of ABE approach and the significances of Population Bioequivalence (PBE) and Individual Bioequivalence
(IBE) approach, current regulatory thinking for assessing different categories of the drug, whether they
are adequately assessed, and the evaluation is in the right direction.
Methods: We carried out an organized search of bibliographic databases for peer-reviewed research literatures, regulatory
recommendations, guidance documents using a focused review question and eligibility criteria. The standard
tools were used to appraise the quality of retrieved documents and to make sure the authenticity of the data.
Results: In total 73 references were used in the review, the majority of the references (guidance documents) were
from the different regulatory agencies and product-specific guidance. There were 29 product-specific guidance from
USFDA and EMA. The limitations of the ABE approach were discussed in detail along with the significances of
Population Bioequivalence (PBE) approach and Individual Bioequivalence (IBE) approaches.
Conclusion: It is apparent from the review that IBE approach is a precise method for evaluating the drugs as it answers
drug interchangeability (prescribability and switchability). IBE approach is followed by PBE approach and
ABE approach for the evaluation of different categories of drugs in terms of precision.