THE APPROVAL OF DRUG PROCESS: A REVIEW
Journal Title: World Journal of Pharmaceutical Research - Year 2018, Vol 7, Issue 5
Abstract
It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing.A new chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Act.‖ The approval of NEW drug requires pre-clinical, Clinical studies (Phase I, II & III), Chemistry, Manufacturing and Control etc. data. Getting approval and successful launching of product into market is very difficult and success rate is very less. Pharmaceutical companies are investing reasonably good amount of money and time to get one drug approval and successful launch into the market.
Authors and Affiliations
Gujral G.
Keywords
Related Articles
- EP ID EP622345
- DOI -
- Views 139
- Downloads 0
ASSESSMENT OF THE POPULATION AWARENESS ABOUT SCHIZOPHRENIA DISEASE AMONG AL-HASA REGION IN SAUDI ARABIA
Schizophrenia is probably the most severe mental disorder, as it is correlated with cognitive deficits, deficits in social functioning and high levels of distress. Schizophrenia most commonly has its onset in early adult...
ROLE OF FREE RADICALS IN PHYSIOLOGY AND PATHOLOGY
Free radicals having unpaired electrons in their outer shell are potent oxidizing or reducing agents against any molecule they happen to contact, making them very toxic in biological systems. ROS such as superoxide radic...
A CRITICAL ANALYSIS OF PURISHDHARAKALA AS ASTHIDHARAKALA W.S.R. TO ASHRAYASHRAYI RELATION AND BASTICHIKITSA
In classical Ayurvedic text Kala is defined as “Dhavtashayantargat maryada”, it means Kala is layer or membrane present between Dhatu and Ashaya. Acharya Sushrut has described Kalasharir in Sharirshtana of Sushrut Samhit...
PREVALENCE OF CERVICAL CANCER AND ASSOCIATED FACTORS AMONG WOMEN IN BAGHDAD / IRAQ
Background: Cervical cancer is a ten most common female cancer in women aged 15-44 years in Iraq with the crude incidence rate 1.7% per 100.000 women per year. Aims: To assess the prevalence of cervical cancer and associ...
LEECH THERAPY IN THE MANAGEMENT OF KNEE OSTEOARTHRITIS-A REVIEW
Leech therapy is a frequently used treatment modality in traditional system of medicine including Unani medicine and involves application of medicinally viable leech species either alone or in combination with pharmacolo...