Prediction of Human Pharmacokinetics and Estimation of First Time in Human Dose

For any drug discovery company, a major milestone is the administration of the clinical drug candidate for the first time in humans. The management, Project members including the pharmacometricians in particular wait anxiously to see how the first patient reacts to the first dose (potential adverse effects) and what the PK of the CD will…

Evaluation of Pharmacokinetic-Pharmacodynamic (PK/PD) Relationships of Anti-Bacterial Agents in Preclinical Models of Infection

Ramesh Jayaraman Director DoseQuantics Consulting INTRODUCTION The pharmacokinetics (time course of concentration in the body) of a drug when combined with its pharmacodynamics (onset, intensity, duration of pharmacological effect of the drug) determines the therapeutic potential of a drug (1).  For an anti-bacterial drug or molecule, the primary measures of in vitro potency and efficacy…