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IDrugs ; 11(1): 36-41, 2008 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-18175261

RESUMO

Developments in translational medicine and regulatory initiatives associated with the FDA's Critical Path Initiative are creating new opportunities for innovation in early clinical R&D. The introduction of the exploratory IND process allows small, 'phase 0' clinical trials to be conducted prior to traditional phase I trials - sometimes requiring considerably less chemistry, manufacturing and controls, or preclinical support. Phase 0 clinical trials involving subtherapeutic, yet pharmacologically active, dose levels can provide an early demonstration of clinical proof of concept; such demonstration is of particular importance to small pharmaceutical and early-stage biotechnology companies. However, these opportunities for rapid entry into the clinic must be balanced by a consideration of the unique risks associated with first-in-human clinical trials, and by accounting for public concerns regarding drug safety in general. This feature review discusses how innovative clinical strategies can be used effectively in early drug development.


Assuntos
Ensaios Clínicos como Assunto/métodos , Drogas em Investigação/uso terapêutico , United States Food and Drug Administration/tendências , Ensaios Clínicos como Assunto/normas , Indústria Farmacêutica/organização & administração , Indústria Farmacêutica/normas , Guias como Assunto/normas , Humanos , Estados Unidos , United States Food and Drug Administration/legislação & jurisprudência , United States Food and Drug Administration/normas
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