Generic substitution: the use of medicinal products containing different salts and implications for safety and efficacy.

@article{Verbeeck2006GenericST,
  title={Generic substitution: the use of medicinal products containing different salts and implications for safety and efficacy.},
  author={Roger Karel Verbeeck and Isadore Kanfer and Roderick Bryan Walker},
  journal={European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences},
  year={2006},
  volume={28 1-2},
  pages={
          1-6
        }
}
In their quest to gain early entry of new generic products into the market prior to patent expiration, one of the strategies pursued by generic drug product manufacturers is to incorporate different salts of an approved active pharmaceutical ingredient (API) in a brand company's marketed dosage form and subject such dosage forms to bioequivalence assessment. These initiatives present challenges to regulatory authorities where the decision to approve bioequivalent products containing such… CONTINUE READING
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