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

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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Torkildsen GL, Abelson M, Gomes PJ. Bioequivalence of two formulations

of ketotifen fumarate opthalmic solution: A single-center, randomized,

double-masked conjunctival allergen challenge investigation in allergic

conjunctivitis. Clin Ther 2008;30:1272-82.

Lainesse A, Hussain S, Monif T, Reyar S, Tippabhotla SK, Madan A, et al.

Bioequivalence studies of tacrolimus capsule under fasting and fed

conditions in healthy male and female subjects. Arzneimittelforschung


Torkildsen GL, Ousler GW 3rd, Gomes PJ. Ocular comfort and drying

effects of three topical antihistamine/mast cell stabilizers in adults with

allergic conjunctivitis: A randomized, double-masked crossover study.

Clin Ther 2008;30:1264-71.

Kumar RS, Istiantoro VW, Hoh ST, Ho CL, Oen FT, Aung T. Efficacy and

safety of a systematic switch from latanoprost to travoprost in patients

with glaucoma. J Glaucoma 2007;16:606-9.

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


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