Food and drug administration′s critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies
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 du...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2010-01-01
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| Series: | Journal of Pharmacy and Bioallied Sciences |
| Subjects: | |
| Online Access: | http://www.jpbsonline.org/article.asp?issn=0975-7406;year=2010;volume=2;issue=4;spage=307;epage=313;aulast=Mahajan |
| _version_ | 1819002564714168320 |
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| author | Rajiv Mahajan Kapil Gupta |
| author_facet | Rajiv Mahajan Kapil Gupta |
| author_sort | Rajiv Mahajan |
| collection | DOAJ |
| description | 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 "Critical Path Initiative" (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. |
| first_indexed | 2024-12-20T23:07:07Z |
| format | Article |
| id | doaj.art-d106efc786744ee3b47e2a292dd8edbf |
| institution | Directory Open Access Journal |
| issn | 0975-7406 0976-4879 |
| language | English |
| last_indexed | 2024-12-20T23:07:07Z |
| publishDate | 2010-01-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Pharmacy and Bioallied Sciences |
| spelling | doaj.art-d106efc786744ee3b47e2a292dd8edbf2022-12-21T19:23:50ZengWolters Kluwer Medknow PublicationsJournal of Pharmacy and Bioallied Sciences0975-74060976-48792010-01-012430731310.4103/0975-7406.72130Food and drug administration′s critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversiesRajiv MahajanKapil GuptaDuring 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 "Critical Path Initiative" (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.http://www.jpbsonline.org/article.asp?issn=0975-7406;year=2010;volume=2;issue=4;spage=307;epage=313;aulast=MahajanBiomarkersclinical trialsdrug developmentmicrodosing |
| spellingShingle | Rajiv Mahajan Kapil Gupta Food and drug administration′s critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies Journal of Pharmacy and Bioallied Sciences Biomarkers clinical trials drug development microdosing |
| title | Food and drug administration′s critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies |
| title_full | Food and drug administration′s critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies |
| title_fullStr | Food and drug administration′s critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies |
| title_full_unstemmed | Food and drug administration′s critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies |
| title_short | Food and drug administration′s critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies |
| title_sort | food and drug administration s critical path initiative and innovations in drug development paradigm challenges progress and controversies |
| topic | Biomarkers clinical trials drug development microdosing |
| url | http://www.jpbsonline.org/article.asp?issn=0975-7406;year=2010;volume=2;issue=4;spage=307;epage=313;aulast=Mahajan |
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