Eyeing opthalmic products: Bioequivalence assessment and drug development - Strategic considerations

Editor AJP

Abstract


The use of pharmacodyamic endpoints has been
reported to assess the bioequivalence of two ophthalmic
formulations of ketotifen.[1] The authors published a well
designed and executed study, which, among other things,included appropriate and a priori defined pharmacodynamic
endpoints in the targeted patient population.[1] The applied
bioequivalence strategy of using pharmacodynamic markers (but
not pharmacokinetics) was adequately justified because of the
lack of quantifiable levels of ketotifen in the systemic circulation
after ocular administration.


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DOI: http://dx.doi.org/10.22377/ajp.v3i2.303

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