Favorite Datasets from Early Phases of Drug Research

Exploratory Pharmacokinetic Study

Part 2 - Table 4


An exploratory pharmacokinetic study was conducted in seven healthy male volunteers to investigate and compare the drug concentration versus time profiles of two stereoisomers of a topical ophthalmic medication. One drop per minute of a 50/50 mixture of the S- and R- isomers was added to each eye for three minutes. Blood sample were drawn and assayed for each isomer at 12 distinct time points during the first 8 hours of dosing: immediately prior to treatment, at 5, 10, 15, 30, and 45 minutes and at 1, 1.5, 2, 4, 6, and 8 hours.

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Part 2 - Table 4
Exploratory Pharmacokinetic Study
Concentrations (ng/ml) of S- and R-Isomers
Minutes Post-Dosing
Subject Isomer 0 5 10 15 30 45 60 90 120 240 360 480
1 S 0 9 18 26 33 39 46 52 37 54 61 66
R 0 9 18 12 26 28 31 24 33 29 23 17
2 S 0 22 47 78 104 142 167 160 173 173 210 186
R 0 26 49 69 100 101 113 126 98 75 57 40
3 S 0 23 29 49 57 69 85 85 107 148 159 174
R 0 15 25 39 55 66 71 69 56 64 59 60
4 S 0 14 35 44 97 108 160 134 146 169 161 150
R 0 24 58 85 99 102 109 103 99 74 47 36
5 S 0 25 38 52 77 86 86 96 131 134 141 144
R 0 14 31 46 56 56 52 52 64 50 32 21
6 S 0 41 73 75 112 64 145 148 182 183 224 188
R 0 38 65 73 76 105 99 105 95 53 38 30
7 S 0 27 37 42 61 86 110 148 140 205 205 202
R 0 31 48 67 98 99 112 125 98 73 57 39


Source:

Bradstreet, T.E. (1992) "Favorite Data Sets from Early Phases of Drug Research - Part 2." Proceedings of the Section on Statistical Education of the American Statistical Association.

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Last modified July 27, 2010 - THS