Open AccessA Comprehensive and Comparative study of qualification process for Drug Development tools in US, Europe, Japan and India.
Author(s) -
Garima Kshatriya,
Dilip Maheshwari
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v6i2.227
Subject(s) - drug development , process (computing) , drug , risk analysis (engineering) , business , process development , process management , medicine , pharmacology , computer science , operating system
Drug Development Tools are methods, materials, or measures that have the potential to facilitate drug development. USFDA has specified three major drug development tools and has also given the guidelines recommending their qualification which would expedite the drug development process. This qualification would ensure better understanding of drug targets and long term safety outcomes. Regulatory authorities of Europe, Japan & India have also focused on developing a formal qualification process of drug development tools though most of it follows USFDA.