@article{AJP_2014, title={Eyeing opthalmic products: Bioequivalence assessment and drug development - Strategic considerations}, volume={3}, url={https://www.asiapharmaceutics.info/index.php/ajp/article/view/303}, DOI={10.22377/ajp.v3i2.303}, abstractNote={<p>The use of pharmacodyamic endpoints has been<br />reported to assess the bioequivalence of two ophthalmic<br />formulations of ketotifen.[1] The authors published a well<br />designed and executed study, which, among other things,included appropriate and a priori defined pharmacodynamic<br />endpoints in the targeted patient population.[1] The applied<br />bioequivalence strategy of using pharmacodynamic markers (but<br />not pharmacokinetics) was adequately justified because of the<br />lack of quantifiable levels of ketotifen in the systemic circulation<br />after ocular administration.</p>}, number={2}, journal={Asian Journal of Pharmaceutics (AJP)}, author={AJP, Editor}, year={2014}, month={Aug.} }