Bioequivalence Assessment of Topical Ophthalmic Drugs Using Sparse Sampling Pharmacokinetics Data

摘要

In the development of eye drop medications,difficulty in sampling is a major challenge[1].Drug concentrations in the aqueous humor(AH)can only be measured when the eye is undergoing surgery,such as cataract replacement.Sampling from tears may significantly reduce the amount of medication remaining in the eye.Owing to limitations caused by sampling difficulty,the concentration–time profile for each subject is generally unattainable when estimating the pharmacokinetics parameters for topical ophthalmic drugs.Instead,each subject can be sampled at one of several prespecified sampling times.