Drug Dosage Principles & Individualisation
Loading, maintenance, special populations and genotype-guided precision dosing
Past RGUHS + DNB + MPMSU + MUHS · 107
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Introduction
- Drug dose — Quantity per unit time intended to keep exposure in the therapeutic window — between minimum effective and minimum toxic concentrations.
- Dose individualisation — Deliberate modification of the labelled dose using patient-specific PK, PD, genotype, demographics, disease state and co-medication; synonyms: personalised dosing, precision dosing.
- Why it matters — NTI drugs (digoxin, lithium, phenytoin, valproate, carbamazepine, aminoglycosides, vancomycin, immunosuppressants, warfarin, theophylline, methotrexate) have a TI < 2–3; inter-individual CL varies 5- to 30-fold even at similar weight and renal function.
- Six levels — (1) Labelled (population), (2) sub-population (paeds/geri/renal/hepatic/pregnancy), (3) demographic (weight/BSA/age/sex), (4) a priori popPK model, (5) a posteriori Bayesian using measured Cp, (6) genotype-guided (CPIC, FDA pharmacogenomic biomarker table).
- PG mandate (RGUHS / NMC PH 1.56) — Compute loading and maintenance from first principles; adjust for renal, hepatic, pregnancy, paediatric, geriatric, pharmacogenetically distinct patients; refine with TDM.
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Drug Dosage Individualisation
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