A Comprehensive and Comparative study of qualification process for Drug Development tools in US, Europe, Japan and India.

  • Garima Kshatriya Gujarat Technological University
  • Dilip G. Maheshwari


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.

Keywords: Drug Development Tools, Qualification, Regulations, Context of Use, Biomarkers, Clinical Outcome Assessment, Animal Models.


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How to Cite
Kshatriya, G., and D. G. Maheshwari. “A Comprehensive and Comparative Study of Qualification Process for Drug Development Tools in US, Europe, Japan and India.”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 2, June 2018, pp. 1-7, doi:10.22270/ijdra.v6i2.227.