Phases of clinical trials: a review
-
Venkata Reddy Samala
B.Pharmacy final year student, Jagan’s Institute of Pharmaceutical Sciences ,Nellore
swamy.cool99@gmail.com
- C.Kiran kumar Associate Professor, Dept.of Pharmacy practice, Jagan’s Institute of Pharmaceutical Science, Nellore.
- P. Venkatesh Principal Jagan’s Institute of Pharmaceutical Science, Nellore
Abstract
A Clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are fastest and safest way to find treatment that work in people and way to improve health. Investigational trials determine whether experimental treatment or new ways of using known therapies are safe and effective under controlled environment. Observational trails address health issues in large groups of people or population in natural settings. Clinical trials aim to measure therapeutic effectiveness and constitute an important and highly specialized form of biological assay. In phase I pharmacokinetic, 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 pharmacologist, if passes hundreds of selected patients are now studied, primarily for safety and therapeutic effectiveness by clinical investigators in phase III. If this is passed the drug is now approved and marketed. Even after marketing, physicians from various hospitals and clinics send their opinion about the drug, regarding ADR, efficacy in phase IV.
Downloads
References
2. Information about clinical trials available https:// genesis research services.com
3. Clinical trials information in https://clinical trials.gov
4. Clinical trial Wikipedia, the free encyclopedia. Jan 28 2008. Available from:URL http://en.wikipedia.org/wiki/cli nical_trial.28 Jan 2008.
5. Dr. Ashutosh Tiwari 2nd Yr. PG Resident Pharmacology Department SAIMS, Indore, 30- 10-2014.
6. Single Ascending Dose & Multi Ascending Dose Information Available in https://www.Nuventra.com
7. Itkar s, Pharmaceutical Management, 3rd Ed, Nirali Prakashan, Pune, 2007, 13.4-13.5.
8. Pharmacists career Profile: Clinical Research / Investigational drug, Available From: URL:http://en.wikipedia.org/wiki/ran domized_controlled_trial.
9. Rasika, walunj M. pharmacy (QAT) Modern College of Pharmacy, Moshi, Pune. Available from https://www.slideshare.net
10. Types of clinical trials available at https://en.m.wikipedia.org
11. ICH Harmonized Tripartite Guideline for Good Clinical Practice ‘Academy For Clinical Excellenge’
12. Pharmacist Role in clinical trial Available from:URL:http://www.nccs.com.sg/m ar 08 /pharmacy.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright © Author(s) retain the copyright of this article.
.