Population Pharmacokinetic Modelling
Existing pharmacokinetic models may be adapted for drugs with long half-lives such as bedaquiline and clofazimine, because limited sampling prevents development of entirely new models. No formal sample-size calculation was performed becaus…
1 sources - 5 claims
Existing pharmacokinetic models may be adapted for drugs with long half-lives such as bedaquiline and clofazimine, because limited sampling prevents development of entirely new models. No formal sample-size calculation was performed because the study is exploratory and power depends on polymorphism frequency, effect size and drug-specific exposure patterns. Allometric scaling will adjust for body size using fixed exponents of 0.75 for clearance and 1 for volume of distribution. The study will use population pharmacokinetic modelling, a non-linear mixed-effects approach suitable for sparse and flexible sampling designs. Genetic effects will enter the population PK model in two stages: first testing known pharmacogenetic markers as covariates, then exploring unexplained between-subject variability against candidate SNPs.