Adequacy of dosing regimens and dosage formulations.
Analysis of drug interactions, toxicity, side effects, population effects.
Invitro-data, animal scale-up, small and large-scale population studies.
Design of clinical trials, analysis of human and animal data, and submission to regulatory and health organizations.
Protocols and final reports for Preclinical, Phases I, II, III and IV of drug development.
Procedures for various types of biomedical measurements, biological sample handling.
Analytical assay methodology design and development.
Pre-clinical data evaluation and extrapolation to man.
Species scale-up; pharmacokinetic, pharmacodynamic and population data analysis and modeling.
Pharmacodynamic and pharmacokinetic data acquisition methods and analytical methodology applied to clinical protocol designs through clinical database fabrication sufficient to support data analysis.
Pharmacodynamic analyses including dose-effect, and dose-response modeling.
Pharmacokinetic and statistical data analysis and evaluation using various mathematical modeling and statistical computer software packages.
Submissions to the FDA.
Study design and analysis, radiocarbon studies, dose escalation studies, drug-drug interaction studies, mass balance and metabolite identification and analyses, and large scale multicenter international efficacy trials.
Drug classes investigated : polypeptides, hormones, anti-inflammatories, antibiotics, cardiac peripheral vasodialators, oncolytics, insulin-like human growth factors, human growth hormones, activated protein C, antipsychotics and other psychotropic agents.