Page - (000090) - in Biomedical Chemistry: Current Trends and Developments

efficient starting doses and dosing regimens for clinical trials; Determine whether a drug is deemed to be suitable for administration to humans on the basis of an acceptable risk assessment. Phase I Investigate whether the compound is safe and well tolerated in humans; Assess pharmacokinetics and pharmacodynamics in humans and investigate the pharmacokinetic attributes of the compound; Evaluate if the compound should move on to further development phases; Establish dosing range and dosage regimens. Tolerability and safety over a range of doses; Measurement of pharmacokinetic parameters using single and multiple doses; Establishing whether plasma concentration increases in proportion to the dose administered in humans; Evaluate the influence of age, gender, genetic characteristics and food on drug pharmacokinetics in humans. Phase II Demonstrate efficacy in the intended population; Identify attributes of the compound in target population compared to the existing therapy; Identify the metabolites and evaluation of their contribution to the biological profile of the compound; Evaluate sex, food and polymorphism influence in drug therapeutic and safety profiles. Quantitative determination of the distribution of a compound in bodily fluids and tissues; Investigate absolute and relative bioavailability; Establishing a clear dose-response relationship; Assessment of the influence of gender and food on pharmacokinetic profiles; Assessment of the influence of genetics in drug metabolizing enzymes on pharmacokinetic profiles. Phase III Demonstrate safety and efficacy for clinical use; Studies at patient Determination of the pharmacokinetic profile in the target population; Determination of the pharmacokinetic profile