Main Article Content
The use of pharmacodyamic endpoints has been
reported to assess the bioequivalence of two ophthalmic
formulations of ketotifen. 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. 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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