Eyeing opthalmic products: Bioequivalence assessment and drug development - Strategic considerations
Main Article Content
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.
Downloads
Article Details
This is an Open Access article distributed under the terms of the Attribution-Noncommercial 4.0 International License [CC BY-NC 4.0], which requires that reusers give credit to the creator. It allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, for noncommercial purposes only.
References
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
;58:242-7.
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.