Drug-demographic

Analysis of response in subsets of the overall population drug-demographic, drug-drug, and drug-disease interactions... 

Drug-Demographic and Drug-Disease Interactions. The information from pharmacokinetic and pharmacodynamic studies as well as clinical trials should be analyzed in the same way as were done to determine drug-drug interactions. 

Our current study of drug use and crime in arrestees in Manhattan overcame some of these measurement problems and enabled us to address some of these basic questions regarding POP use and crime. The recent use of PCP (as well as other drugs) in male arrestees was measured by a urinalysis of a specimen obtained within hours after arrest. We therefore did not have to rely on each person s accurate report that he had taken PCP. We shall use the urinalysis test results, with information from interviews with the arrestees, and from their criminal records, to describe the prevalence of PCP use in arrestees, the demographic characteristics of users and the types of offenses for which they are arrested. The next section describes our study of drug use and crime in arrestees in Manhattan. 

Demographics and Trial-Specific Baseline Data 27 Concomitant or Prior Medication Data 27 Medical History Data 29 Investigational Therapy Drug Log 30 Laboratory Data 31 Adverse Event Data 32 Endpoint/Event Assessment Data 35 Clinical Endpoint Committee (CEC) Data 36 Study Termination Data 37 Treatment Randomization Data 38 Quality-of-Life Data 40... 

Pharmacokinetic concentration-time curves for a drug and ifs mefabolifes are used to identify primary exposure metrics such as AUC, or which are not time-dependent unlike the sequential measurements of concentration over time. A peak plasma concentration of a drug is often associated with a PD response, especially with an adverse event. There can be large inter-individual variability in the time-to-peak concentration, and closely spaced sampling times are often critical to determining the peak plasma concentration accurately in individual patients because of differences in demographics, disease states, and food effects, if any. All these elements are clearly spelled out in the protocols written to conduct these studies. 

The explanation of variability by identifying factors of demographic, pathophysiologic, environmental, or concomitant drug-related origin that may influence the PK behavior of a drug. 

After the successful completion of the Phase II trial, the objective of Phase III is to confirm the efficacy of the drug in a large patient group. Phase III is an extension of Phase II, and the trial is normally conducted in several hospitals in different demographic locations, to determine the influence of ethnic responses, together with incorporation of new criteria for fine-tuning the trial. This trial is also known as a multisite trial. 

Tsuang MT, Simpson JC, Kronfol Z. (1982). Subtypes of drug abuse with psychosis. Demographic characteristics, clinical features, and family history. Arch Gen Psychiatry. 39(2) 141-47. 

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