A Comprehensive and Comparative study of qualification process for Drug Development tools in US, Europe, Japan and India Kshatriya Garima*, Maheshwari Dilip G. Department of Quality Assurance and Pharm Regulatory Affairs, LJIP, Ahmedabad, Gujarat, India *Corresponding author. Tel.: +91-8460265728; E-mail address: garimakshatriya17@gmail.com (G. Khsatriya)
Online published on 17 September, 2019. Abstract 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. Top Keywords Drug Development Tools, Qualification, Regulations, Context of Use, Biomarkers, Clinical Outcome Assessment, Animal Models. Top |