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

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.

Implications of Porphyromonas gingivalis peptidyl arginine deiminase and gingipain R in human health and diseases

“…A typical drug discovery pipeline tends to be time consuming and costly. FDA approval process for newly developed drugs took an average of 12 years ( Van Norman, 2016 ) and roughly 800 million to 1 billion U.S dollars were spent for every successful FDA approved drug ( Khurana et al., 2018 ). As such, the drug repurposing approach, i.e., finding new uses for existing pharmaceuticals, could be of immense utility.…”

Optimization of 1,4-Naphthoquinone Hit Compound: A Computational, Phenotypic, and In Vivo Screening against Trypanosoma cruzi

“…The discovery and development of new drugs is a time-consuming (average 10–15 years) and costly ($800 million to $1 billion) process, which makes it a great challenge for the efficient and safe treatment of various diseases [ 35 ]. Despite the increased success rate of molecular entity approval in recent years (2017–2018) [ 36 ], only 1.65% of the new products for treatment of neglected tropical diseases (NTDs) entered phase I clinical trial [ 37 ]. Among the 20 NTDs proposed for control or elimination by 2020, Chagas disease (CD), discovered 110 years ago, has made little progress in finding new drugs effective in treating the disease.…”

Extraction the Dayak Onion (Eleutherine sp): Scientific Based Herbal Medicine (OHT) Production Protocol

“…Molecular bioactive compound analysis of Dayak onion has the potential to be new drugs work on specialized organ systems or genetic manipulations. [17][18][19] At the development stage, the Dayak onion potential compounds were conducted identification and experimentation. We have gathered information about: absorption, distribution, metabolism and excretion; benefits and working mechanism; the best route of administration; the side effects and toxicity; the results if given two different sexes, races or ethnics; interaction with other drugs and treatment methods; and effectiveness compared to similar drugs.…”