Types of studies. (i) Pharmaco- kinetics studies. Groups A through F shall be used to determine the kinetics of absorption of the test substance. In groups administered the substance by intravenous or oral routes, (i.e., Groups A, B, C, F), the concentration of radio- activity in blood and excreta including expired air shall be measured following administration. In groups administered the substance by the inhalation route (i.e., Groups D and E), the concentra- tion of radioactivity in blood shall be measured at selected time intervals during and following the exposure pe- riod. In the groups administered the substance by inhalation (i.e., Groups D and E), the concentration of radioac- tivity in excreta (including expired air) shall be measured at selected time in- tervals following the exposure period. In addition, in the groups administered the substance by inhalation, the con- centration of test substance in inspired air shall be measured at selected time intervals during the exposure period.
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Sources: Testing Consent Agreements and Test Rules, Testing Consent Agreements and Test Rules, Testing Consent Agreements and Test Rules