부산대학교 도서관

Clinical Trial: - A clinical trial is a systematic investigation in human subjects for evaluating the safety and efficacy of new drug. The clinical research process includes: * Preclinical testing * Investigational New Drug Application (IND) * Phase I (assess safety) * Phase II (test for effectiveness) * Phase III (large-scale testing) * Licensing (approval to use) * Approval (available for prescription) * Post-marketing studies (special studies and long-term effectiveness/use) Research is important because: * Clinical trials test how well new approaches and interventions work in people * These approaches can be medical, behavioral, or management Each study helps scientists prevent, screen for, diagnose, manage, and treat a disease . People who take part in clinical trials contribute to the knowledge of how a disease progresses. A clinical trial is a research study that tests a new medical treatment or a new way of using an existing treatment to see if it will be a better way to prevent and screen for diagnose or treat a disease. Phase 0 clinical trial The Phase 0 clinical trial is the latest designation for the exploratory, First-In-Humans trials conducted according to the FDA 2006 Guidance on exploratory Investigational New Drug (IND) studies. Phase 1 clinical trial * Phase I trials are the first stage of testing in human subjects. Normally, a small (20-80) group of healthy volunteers will be selected. * This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. Phase 2 trials gives a successful design for phase 3 trials which carried out in multiple centres Phase 2 trials divided into * Phase 2a (how drug should be given and how often) * Phase 2b ( how well drug works at prescribed doses ) Clinical trial basically used to determine the weather of new drug clinical trial is scientific study of drug. [ABSTRACT FROM AUTHOR]