Journal of Pharmacy And Bioallied Sciences

REVIEW ARTICLE
Year
: 2010  |  Volume : 2  |  Issue : 4  |  Page : 307--313

Food and drug administration俟Q製 critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies


Rajiv Mahajan1, Kapil Gupta2 
1 Department of Pharmacology, Adesh Institute of Medical Sciences and Research, Bathinda - 151 109, India
2 Department of Biochemistry, Adesh Institute of Medical Sciences and Research, Bathinda - 151 109, India

Correspondence Address:
Rajiv Mahajan
Department of Pharmacology, Adesh Institute of Medical Sciences and Research, Bathinda - 151 109
India

During the last decade, despite increased investment in drug research and development related activity, stagnation in new drug discovery has been documented. Despite a 70% increase in investment in research and development-related activities, a 40% fall in launch of new chemical entities was seen during 1994-2004. A steep rise in the attrition rate of drug development has complicated the matter. Rising cost and increased attrition rates proved major barriers to investment in higher risk drugs or in therapies for uncommon diseases or diseases that predominantly afflict the poor. This prompted Food and Drug Administration (FDA) to highlight this problem in a 2004 white paper classified as 非Q翟ritical Path Initiative非Q (CPI) and to initiate steps to target stagnation and rise in attrition rates. Many new drug development projects have started worldwide taking cue from CPI; adopting microdosing, adaptive designs and taking advantage of newly developed biomarkers under the CPI. This review discusses the various strategies adopted under CPI to decrease attrition rate and stagnation of new drug development, and the challenges and controversies associated with CPI.


How to cite this article:
Mahajan R, Gupta K. Food and drug administration's critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies.J Pharm Bioall Sci 2010;2:307-313


How to cite this URL:
Mahajan R, Gupta K. Food and drug administration's critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies. J Pharm Bioall Sci [serial online] 2010 [cited 2022 Jun 24 ];2:307-313
Available from: https://www.jpbsonline.org/article.asp?issn=0975-7406;year=2010;volume=2;issue=4;spage=307;epage=313;aulast=Mahajan;type=0