Common use of Types of studies Clause in Contracts

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 animal subjects administered the test substance intravenously (i.e., Group A), the concentration of test substance in blood and excreta shall be measured following administration. In animal subjects administered the test sub- stance by the inhalation and dermal routes (i.e., Groups B through F), the concentration of test substance in blood shall be measured at selected time intervals during and following the exposure period. In animal subjects ad- ministered the test substance by the inhalation route (i.e., Groups B, C, and F) the concentration of test substance in excreta shall be measured following exposure. In animal subjects adminis- tered the test substance by the dermal route (i.e., Groups D and E) the con- centration of test substance in excreta shall be measured during and following exposure. These measurements allow calculation of uptake, half lives, and clearance. In addition, in the groups administered the test substance by in- halation (i.e., Groups B, C, and F), the concentration of test substance in the exposure chamber air shall be meas- ured at selected time intervals during the exposure period.