Investigational New Drug Application and Approval Process

Authors

  • Irfan Siraj Menda Department of Quality Assurance, Shri B.M.Shah College of Pharmaceutical Education & Research, Modasa-383315, India.

Abstract

ABSTRACT The investigational new drug (IND) application is the result of a successful preclinical development program. The IND is also the vehicle through which a sponsor advances to the next stage of drug development known as clinical trials (human trials). This article will focus the approval process of investigational new drug & its approval by regulatory bodies.IND Application is the precursor of NDA Process. This article, which emphasis on easy access to understanding how this agency (USFDA) operates with respect to practical aspect of IND & its approval process. USFDA establish process albeit need to improve IND Application process.

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How to Cite

Menda, I. S. (2011). Investigational New Drug Application and Approval Process. International Journal of Pharmaceutical & Biological Archive, 2(4). Retrieved from http://ijpba.info/index.php/ijpba/article/view/334

Issue

Vol. 2 No. 4 (2011): IJPBA

Section

Review Articles

License

This is an Open Access article distributed under the terms of the Attribution-Noncommercial 4.0 International License [CC BY-NC 4.0], which requires that reusers give credit to the creator. It allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, for noncommercial purposes only.