WJPR Citation New

  All Since 2011
 Citation  2903  2393
 h-index  27  24
 i10-index  68  60

Login

Best Paper Awards

World Journal of Pharmaceutical Research (WJPR) will give best paper award in every issue in the form of money along with certificate to promote research activity of scholar.
            Best Paper Award :

Download Article: Click Here

Search

Track Your Article

Abstract

FILING REQUIREMENTS FOR INVESTIGATIONAL NEW DRUG APPLICATION IN UNITED STATES AND CLINICAL TRAIL AUTHORIZATION IN EUROPE

*M. Ghazala Firdous, M. V. Nagabhushanam, G. Ramakrishna

Abstract

Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process and filing requirements for Investigational New Drug Application (IND) in United States and Clinical Trail Authorization in Europe.

Keywords: Investigational New Drug Application (IND), MAA, USFDA, Drug approval, Clinical trial Authorization.


[Full Text Article]

Call for Paper

World Journal of Pharmaceutical Research (WJPR)
Read More

Email & SMS Alert

World Journal of Pharmaceutical Research (WJPR)
Read More

Article Statistics

World Journal of Pharmaceutical Research (WJPR)
Read More

Online Submission

World Journal of Pharmaceutical Research (WJPR)
Read More