Final answer:
The objectives of human pharmacology studies are to assess pharmacokinetics and pharmacodynamics in humans, investigate the safety and pharmacokinetic profiles of compounds, and determine the influence of various factors on drug pharmacokinetics. These studies are critical across the stages of drug development, from discovery through clinical trials.
Step-by-step explanation:
Human Pharmacology Study Objectives
The objectives of human pharmacology studies include a comprehensive examination and understanding of pharmacokinetics (PK) and pharmacodynamics (PD) in humans. This involves the investigation of pharmacokinetic attributes of multiple doses of a compound, as well as evaluating factors such as the influence of age, gender, genetic characteristics, and food on drug pharmacokinetics.
During drug development, pharmacokinetic studies are crucial from initial discovery to phase IV clinical development. These studies aim to predict pharmacokinetic parameters, evaluate the safety and tolerability of compounds in humans, and characterize the pharmacokinetic profile of the parent compound and its main metabolites. Clinical development starts with phase I trials to assess if a compound is safe and well-tolerated in humans, which includes studying the absorption and elimination phases of the plasma.
Other key objectives in pharmacology involve the integration of PK and PD data to understand the pharmacology in animals from different species, preparation for clinical development based on specific guidelines, and the application of both compartmental and non-compartmental methods to determine multiple pharmacokinetic parameters, such as maximum concentration (Cmax), elimination half-life (tââ), and bioavailability.