ISSN: 2048-9145

Pharmaceutical Bioprocessing

Open Access Clinical Pharmacology Journals

Study of the pharmacokinetics (PK) and Pharmacodynamics (PD) of the drug in humans – PK: what the body do to the drug (Absorption, Distribution, Metabolism, Excretion) – PD: what the drug will to the body • PK and PD profiles of the drug ar influenced by physicochemical properties of the drug, product/formulation, administration route, patient’s intrinsic and adventitious factors (e.g., organ dysfunction, diseases, concomitant medications, food).  ADME - to know the complete clearance mechanisms of the drug and its metabolites in humans • generally single dose, healthy males (n=4-6), at supposed route of administration • Radio-labelled (C14) drug molecule • live concentrations of parent and metabolite(s) and verify amount of radiation in plasma, urine, faecal matter • data gained: – Primary mechanism(s) of elimination and excretion from the body – Proportion of parent drug reborn to metabolite(s).   Bioavailabilty and Bioequivalence - to guage the speed (Cmax, Tmax) and extent (AUC) of absorption of drug from a check formulation (vs. reference formulation) • BA:Typically, crossover, single dose (if linear PK) study in healthy subjects; live blood/plasma conc. of parent drug and major active metabolites for ≥ three t½ BE: crossover study in fasted healthy subjects given single doses of check & reference product administered at same molar doses; live blood/plasma conc. of parent drug solely  

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