Demographic characteristics subjects

A similar table may be presented for demographic characteristics. Specific characteristics that are important can vary from study to study, but typical ones include gender, age, race, and baseline data of relevance, e.g., weight, blood pressure, and heart rate. Information concerning the use of concomitant or concurrent medications and evaluations of subject adherence or compliance with the trial s treatment schedule is also typically presented. 

In general, multiple (up to 30-40) blood samples can be obtained per subject to measure dmg and metabolite concentrations as well as biomarkers in these phase I clinical trials. Furthermore, pharmacodynamic measurements can be included to get a first impression on the drug effect in humans, however, limited by the fact that healthy volunteers were studied and not patients. As strict inclusion and exclusion criteria are used, the demographic characteristics of the healthy volunteers do not provide sufficient spread to investigate the effect of intrinsic factors. Therefore, phase I trials provide very rich data to develop pharmacokinetic and pharmacodynamic models on biomarker, but cannot be used to develop models for efficacy, safety, influence of patient factors on PK and/or PD and disease progression. 

When we create two groups by dividing subjects on the basis of one demographic characteristic, but find the resulting groups also tend to differ in other ways, there is confounding. 

Thus, a multiple dose study was performed in which all healthy and hepatic impaired individuals, received the same dose. It was the aim to include 12 patients with various and well distributed degrees of hepatic impairment (according to the Child-Pugh score) and 12 pair-matched (based on demographic characteristics) healthy subjects, in order to have 10 patients and 10 subjects evaluable. The pharmacokinetics of XYZ123 in plasma (total and unbound) and in urine was assessed after the first dose and at steady state after the seventh dose. The pharmacokinetics in plasma of its main metabolite XYZ456 was also assessed. 

In this notation, g(9, zj) is used to represent a function (g), perhaps a linear combination of CO variates, that describes the expectation of the /th subjects parameter vector 9i conditional on their demographic characteristics (z,) and population parameter values (0). The variance-covariance matrix (Q) therefore describes the random variability between subjects that is not able to be explained by covariates. 

Clinical Laboratory Evaluation in Clinical Trials. In this section, data from individual trials should be combined and analyzed. Relationships between laboratory tests and clinically relevant subsets of subjects as well as particular adverse experiences and laboratory abnormalities should be assessed. The relationship of drug-related abnormalities to dose, duration of treatment, and subject demographic characteristics should be explored where applicable. 

Subjects are normal healthy volunteers living or waking for at least 1 year in their constant macro- and micro-environment. Nine hundred and seventy-seven people were examined, among them there were 140 children. Demographic characteristics of persons are shown in Table 15.1. Donors were distributed into 8 groups, according to the place of their residence, outdoor and indoor exposure types and age. The first Budapest community... 

Baseline and Demographic Characteristics of Subjects (Intent-to-Treat Analyses) ... 

By contrast, in the population approach, the raw data set that is analysed consists of concentration-time points (and other necessary data such as demographic information) taken from a large number (up to hundreds to thousands) of patients in Phase 11 and/or Phase 111 trials. The number of plasma samples per subject may be sparse but it is possible to estimate the individual pharmacokinetic characteristics of each subject and hence a measure of the mean parameters and their variability can be assessed. Relationships can be sought between patient characteristics (demographics, chnical status) and pharmacokinetic values is found, its consequence may be examined by looking for altered efficacy or safety which may not be possible in a traditional volunteer study. This might lead to demonstration of a therapeutic concentration range. 

Analysis of Adverse Effect Dose-Response Information. An integrated analysis of all data from animal and human trials that affect the dose-response and blood level-response relationships of adverse experiences, the method of dose selection, the choice of dose interval, and dosing recommendations in the package insert should be performed. The effect of demographics and other subject characteristics on the dose-response relationships should be explored. 

Data Sets Analyzed, (a) Which subjects are included in the efficacy and safety analyses should be precisely defined. If the analyses are based on a subset of the subjects with data, an intent-to-treat analysis of all randomized subjects should also be performed, (b) Demographic and Baseline Features of Individual Subjects and Comparability of Treatment Groups. Critical dem ographic and baseline characteristics of the subject population and any other factors that might affect response should be presented comparability of treatment groups for each relevant characteristic should be documented. If there is an effectiveness subset of subjects as well as an intent-to-treat popu lation, this... 

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