REGULATORY STRATEGIES FOR FILING OF NDA IN ICH COUNTRIES (US, EUROPE and JAPAN)
Journal Title: International Journal of Pharmaceutical Development & Technology - Year 2015, Vol 5, Issue 2
Abstract
ABSTRACT Developing new drugs 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, efficacy 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 in different countries like USA, Europe and Japan. Keywords: MAA, USFDA, Drug approval process, Clinical Trial.
Authors and Affiliations
Priyanka Gangarapu, P. Jayachandra Reddy, M. Alagu Sundaram, M. Sabareesh, V. Prabhakaran
Keywords
Related Articles
- EP ID EP128354
- DOI -
- Views 90
- Downloads 0
RECENT TRENDS IN CONTROLLED RELEASE ORAL DRUG DELIVERY SYSTEMS: A COMPREHENSIVE REVIEW
ABSTRACT In recent decades different modern technological attempts have been explored in the research and development of controlled release oral drug delivery systems to cross the barriers of physiological advers...
MULTIVARIATE UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF EMTRICITABINE IN BULK FORM
ABSTRACT To develop a simple, precise and accurate UV-method with multivariate calibration technique for estimation of emtricitabine in bulk form. This technique is based on the use of the linear regression equat...
PROCESS VALIDATION OF VALACYCLOVIR TABLETS BY OPTIMISING PROCESS PARAMETERS
In the present study, Valacyclovir tablets were formulated using different formulation parameters and their effects on the dissolution rate of these tablets were evaluated. The binding agent used in this study was...
REVIEW ON NANOSUSPENSION TECHNOLOGY
ABSTRACT Solubility is an essential factor for drug effectiveness, independent of the route of administration. Poorly soluble drugs are often a challenging task for formulators in the industry. Large proportions...
A RENEWABLE BIO-DIESEL FROM MICRO-ALGAE (A FUTURE’S NEED)
ABSTRACT Biodiesels (fatty acid methyl esters) derived from oleaginous microbes (microalgae, yeast, and bacteria) are being actively pursued as potential renewable substitutes for petroleum diesel. Continued use...