Types of studies. (i) Pharmaco- kinetics studies—(A) Rat studies. Groups A through F shall be used to determine the kinetics of absorption of the test substance. In the group administered the test substance by intravenous routes, (i.e., Group A), the concentra- tion of radioactivity in blood and ex- creta shall be measured following ad- ministration. In groups administered the test substance by the oral and der- mal route (i.e., Groups B, C, D, E and F), the concentration of radioactivity in blood and excreta shall be measured at selected time intervals during and following the exposure period.
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.
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 40 CFR Ch. I (7–1–14 Edition) 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.
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 § 795.231 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.
Types of studies. (a) From time to time MFI and HBI may agree to joint multi-client studies using the internet ("JV MULTI-CLIENT STUDY(IES)").
Types of studies. (i) Pharmaco- kinetics studies—(A) Rat studies. Groups A through F shall be used to determine the kinetics of absorption of the test substance. In the group administered the test substance by intravenous routes, (i.e., Group A), the concentra- tion of radioactivity in blood and ex- creta shall be measured following ad- ministration. In groups administered Environmental Protection Agency § 795.228 the test substance by the oral and der- mal route (i.e., Groups B, C, D, E and F), the concentration of radioactivity in blood and excreta shall be measured at selected time intervals during and following the exposure period.
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 Environmental Protection Agency § 795.231 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.
Types of studies. Studies that have a) developed/described; or b) tested prospectively at least one standardized model that consists of a systematic method of appraising risk of harm posed to a child, within a European or UK context, and assisting case decision-making [or a model, developed elsewhere, which could potentially be used in the UK].
Types of studies. For the assessment of effectiveness; good quality systematic reviews of experimental and observational studies, randomised controlled trials, controlled non-randomised studies, controlled and uncontrolled before and after studies, cross-sectional studies, cohort studies, case-control studies and ecological studies. For the assessment of cost-effectiveness; economic evaluations conducted alongside trials, modelling studies and analyses of administrative databases. Only full economic evaluations that compare two or more options and consider both costs and consequences (including cost-effectiveness, cost-utility and cost-benefit analyses) will be eligible. For the review of qualitative literature; studies of any qualitative design will considered for inclusion, for example, ethnographic studies, studies that use a phenomenological or grounded theory approach, or participatory action research. For studies based on mixed methods research, both the qualitative and quantitative elements will be screened for inclusion. Types of interventions Interventions involving the distribution of needles, syringes and other injection equipment (e.g. filters, mixing containers and sterile water) will be eligible. As in the original reviews, needle and syringe exchange programmes (NSPs) are defined as the supply of needles, syringes and other injection equipment for the preparation and consumption of drugs.
