Basic Principles And Objectives Of Clinical Pharmacology Studies

Clinical pharmacology studies are one of the most interesting clinical studies conducted during the clinical development of any new pharmaceutical product. Depending upon the pharmacological or therapeutic class of the product, it mainly involves different kinds of phase 1 studies. Clinical pharmacology studies are very specialized studies and are conducted with specific objectives to understand safety, tolerability, pharmacokinetics and / or pharmacodynamics of the drug. Not only designing of such studies, but conducting, analyzing and interpreting results of such studies are challenging. Designing such studies requires understanding of basic and clinical pharmacology as well as understanding of feasibility of conducting the studies. Conducting such studies requires knowledge and clinical skills. Bioanalytical knowledge and skills are required for bioanalysis in order to estimate the drug and / or metabolites of interest. For data analysis and interpretation; knowledge of pharmacokinetics, pharmacodynamics and biostatistics is required. Thus, such studies involve team of scientists from different disciplines including basic and clinical pharmacologists, clinicians, medical emergency experts, bioanalytical experts and statisticians. Results of such studies creates excellent base for phase 2 proof of concept studies. Some of these studies are also conducted in parallel or after phase 2 or phase 3 studies to address specific need.  In this article, authors have summarized various clinical pharmacology studies with their basic principles and key objectives.