Abstract

A REVIEW ON CLINICAL TRIALS AND ROLE OF PHARMACIST

R. Sridhar*, Ch. V. Hemanth and N. Durga Deepak

ABSTRACT

A clinical trials is a research study in human volunteers to answer specific health questions. Investigational trails determine whether experimental treatment or new ways of using known therapies are safe and effective under controlled environment. Clinical trials aims to measure therapies effectiveness and constitute an important and highly specialized form of biological assay. In phase I pharmacokinetics, safety, gross effects are studied on human volunteers by clinical pharmacologists. If the drug passes the test, it enters phase II testing, where pharmacokinetics safety, therapeutic efficiency are studied on selected patients by clinical pharmacologists, if passes hundreds of selected patients are now studied, primarily for safety and therapeutic effectiveness by clinical investigator in phase III. If this is passed the drug is now approved and marketed.

Keywords: Clinical trials, Preclinical Studies, Clinical studies, NDA.