Title:Drug Development Process and Novel Drugs Approved by FDA for 2017-18
VOLUME: 5 ISSUE: 2
Author(s):Gaurav Khurana, Aashu Rohilla and Aakash Deep*
Affiliation:Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, Haryana, Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, Haryana, Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, Haryana
Keywords:Drug discovery, drug development, health care products, FDA approved drugs, pharmaceutical
research companies.
Abstract:Delivering authentic healthcare Innovation worldwide is a demanding and
complex task. The global discovery and approval of new drugs, medical devices and biologics
will revolutionize the availability of health care products worldwide. The
mission of pharmaceutical research companies is to discover and develop new drugs
with safe and effective treatment to patients. Drug development is a science-driven
process that at its base involves exploiting biological processes to trigger a therapeutic
benefit. The process of discovering and developing a new molecular entity on average
requires approximately 13.5-15 years. The developer must reveal efficacy and safety for
a novel new drug to become commercially available. A drug in human subjects is
governed by rules that fall under the responsibility of overseeing the US Food and Drug
Administration. The average cost for the research and development of each successful
drug is estimated at $ 800 million to $ 1 billion. The discovery process includes the first
steps of the investigation, which are designed to identify a drug in the research and
perform initial tests in the laboratory. In this article, we focused on the drug discovery,
development process and list of new drugs approved by U.S. Food and Drug Administration
(FDA) in 2017.
