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USFDA/EMEA/CANADA/Japan/WHO Guidelines on BioEquivalence (Part-1)

Bioequivalence (BE) study is largely established via clinical pharmacokinetic (PK) studies or comparative in vitro dissolution studies. BE assessment  is important for establishing therapeutic equivalence for generic drug products to their respective comparator products. In addition, application of the BE concept is important for bridging various formulations during new (innovator) drug development. Furthermore, BE studies are used by innovator and generic product developers to bridge certain types of post approval formulation changes. 

Here we summerize few points on criteia for test product and manufacturing of bio batch -

Criteria for Test Product (TP)

  • Single unit of highest (marketed) strength should be administered. 
  • If any bioanalytical sensitivity issues - 2/+ units can be administered - but not exceed max. daily dose. 
  • Use lower strength when there are safety concerns (ex: psychotic drugs).
  •  Lot/ Batch number with Exp. date to be mentioned.
  • Assay content of TP should within +/- 5% of RP.
  • Side by side comparison of composition to be provided.
  • Both TP & RP must be retained for 5 years.
  • The test product should be representative of the product to be marketed.

For manufacturing:

  • The test product should usually originate from a batch of AT LEAST 1/10 OF PRODUCTION SCALE or 100,000 UNITS, WHICHEVER IS GREATER. In case of a production batch smaller than 100,000 units, a full production batch will be required.
  • The production of batches used should provide a high level of assurance that the product and process will be feasible on an industrial scale.
  • The characterization and specification of CQA of the drug product, such as dissolution, should be established from the test batch, i.e. the clinical batch for which bioequivalence has been demonstrated.
  • Comparative dissolution profile testing should be undertaken on the first three production batches.

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