Drug Development Process and Novel Drugs Approved by FDA for 2017-18

Author(s): Gaurav Khurana, Aashu Rohilla, Aakash Deep*.

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

Volume 5 , Issue 2 , 2018

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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.

Keywords: Drug discovery, drug development, health care products, FDA approved drugs, pharmaceutical research companies.

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Article Details

VOLUME: 5
ISSUE: 2
Year: 2018
Page: [80 - 98]
Pages: 19
DOI: 10.2174/2213476X05666180604083001

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