Populational PKPD Analysis Flashcards
The ______ used to measure drug concentrations also has variability.
Assays.
Variability is not a major concern for what drugs.
Those that don’t have a narrow therapeutic window.
Factors affecting PK/PD are known as ____________
Covariates.
This form of PK analysis focuses on:
1. Homogenous Population
2. Single Dose Studies
3. Small Study Groups
4. Intensive Sampling
Traditional PK analysis
This form of PK analysis focuses on:
1. Phase II/III Trials
2. Heterogenous patient population
3. Lack of simple experimental paradigm
4. Sparse sampling strategies
5. Complicated and time-intensive analysis.
Routine Clinical Trials.
Quantitative relationship between parameter values and co-variates.
Covariate Model of Populational Analysis
Variability of parameter values across populations of patients.
Statistical Model of Populational Analysis.
Analyzes mean PK parameters.
Structural Model of Populational analysis.
In populational analysis what is epsilon?
The distance from the population to the observed data for an individual patient.
Estimate population mean parameters by treating all data as if it were from the same individual.
Naive Pooled Data
Estimate each individual’s PK and then use individual parameters to estimate the population mean parameters.
Standard Two-Stage Model
This is the gold standard of populational analysis.
Nonlinear Mixed Effects Modeling.
Estimates fixed and random effect populational parameters simulataneously.
Nonlinear Mixed Effects Modeling.
Use prior distribution of parameters in a population of subjects and data from an individual to estimate the individual’s parameters.
Bayesian Estimation.
In _____________, all data points are assumed to arise from a single individual.
Naive Pooled Data