Population Pharmacokinetic Modelling

How it works

Comparisons

Evidence quality

Highlighted claims

• The study will use population pharmacokinetic modelling, a non-linear mixed-effects approach suitable for sparse and flexible sampling designs. — Population-based study of pharmacogenetics and pharmacokinetics in Southern African patients with multidrug-resistant tuberculosis (PoPG): a protocol for the Namibian cohort
• Allometric scaling will adjust for body size using fixed exponents of 0.75 for clearance and 1 for volume of distribution. — Population-based study of pharmacogenetics and pharmacokinetics in Southern African patients with multidrug-resistant tuberculosis (PoPG): a protocol for the Namibian cohort
• 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. — Population-based study of pharmacogenetics and pharmacokinetics in Southern African patients with multidrug-resistant tuberculosis (PoPG): a protocol for the Namibian cohort
• 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. — Population-based study of pharmacogenetics and pharmacokinetics in Southern African patients with multidrug-resistant tuberculosis (PoPG): a protocol for the Namibian cohort
• 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. — Population-based study of pharmacogenetics and pharmacokinetics in Southern African patients with multidrug-resistant tuberculosis (PoPG): a protocol for the Namibian cohort