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

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Editor AJP


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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How to Cite
AJP, E. (2014). Eyeing opthalmic products: Bioequivalence assessment and drug development - Strategic considerations. Asian Journal of Pharmaceutics (AJP), 3(2). https://doi.org/10.22377/ajp.v3i2.303


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