The FDA critical path initiative and its influence on new drug development.
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Anticancer properties of nimbolide and pharmacokinetic considerations to accelerate its developmentTranslational challenges of animal models in Chagas disease drug development: a reviewA novel knowledge representation framework for the statistical validation of quantitative imaging biomarkersQuestioning the preclinical paradigm: natural, extreme biology as an alternative discovery platformIdentification of direct target engagement biomarkers for kinase-targeted therapeuticsThreats to validity in the design and conduct of preclinical efficacy studies: a systematic review of guidelines for in vivo animal experimentsGenomic responses in mouse models poorly mimic human inflammatory diseasesImaging biomarker roadmap for cancer studiesCardiac models in drug discovery and development: a review.ESR statement on the stepwise development of imaging biomarkers.Inter-Method Performance Study of Tumor Volumetry Assessment on Computed Tomography Test-Retest Data.Structural analysis and molecular docking of trypanocidal aryloxy-quinones in trypanothione and glutathione reductases: a comparison with biochemical data.Paving the Way to Personalized Genomic Medicine: Steps to Successful Implementation.Using NMR approaches to drive the search for new CNS therapeutics.Quantitative imaging test approval and biomarker qualification: interrelated but distinct activities.Timelines of translational science: From technology initiation to FDA approvalChallenges in conducting clinical trials in children: approaches for improving performancePharmacokinetic/ pharmacodynamic-driven drug developmentBlood cytokines as biomarkers of in vivo toxicity in preclinical safety assessment: considerations for their use.Adaptive design clinical trials: Methodology, challenges and prospectProspective validation of the provisional criteria for the evaluation of response to therapy in childhood-onset systemic lupus erythematosusThe innovative medicines initiative: a European response to the innovation challenge.Public-private partnerships need honest brokering.Toward an integrated research agenda for critical illness in agingFood and drug administration's critical path initiative and innovations in drug development paradigm: Challenges, progress, and controversies.Quantitative Systems Pharmacology can reduce attrition and improve productivity in pharmaceutical research and development.Quantitative imaging biomarkers: a review of statistical methods for computer algorithm comparisons.Human enteroids as an ex-vivo model of host-pathogen interactions in the gastrointestinal tractBiological markers for early detection and pharmacological treatment of Alzheimer's disease.Evidence-based translation for the genomic responses of murine models for the study of human immunity.Multiscale Modeling of Drug-induced Effects of ReDuNing Injection on Human Disease: From Drug Molecules to Clinical Symptoms of Disease.Network pharmacodynamic models for customized cancer therapy.Anticancer activity of an imageable curcuminoid 1-[2-aminoethyl-(6-hydrazinopyridine-3-carbamidyl)-3,5-bis-(2-fluorobenzylidene)-4-piperidone (EFAH)Unraveling the autoimmune translational research process layer by layer.What is happening with the supply of oncology drugs in Brazil and the world?NCI-RTOG translational program strategic guidelines for the early-stage development of radiosensitizers.Public-private partnerships as driving forces in the quest for innovative medicinesHuman Enteroids/Colonoids and Intestinal Organoids Functionally Recapitulate Normal Intestinal Physiology and Pathophysiology.Disease signatures for schizophrenia and bipolar disorder using patient-derived induced pluripotent stem cells.Mechanistic biomarkers for clinical decision making in rheumatic diseases.
P2860
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P2860
The FDA critical path initiative and its influence on new drug development.
description
2008 nî lūn-bûn
@nan
2008 թուականի Յունուարին հրատարակուած գիտական յօդուած
@hyw
2008 թվականի հունվարին հրատարակված գիտական հոդված
@hy
2008年の論文
@ja
2008年論文
@yue
2008年論文
@zh-hant
2008年論文
@zh-hk
2008年論文
@zh-mo
2008年論文
@zh-tw
2008年论文
@wuu
name
The FDA critical path initiative and its influence on new drug development.
@ast
The FDA critical path initiative and its influence on new drug development.
@en
The FDA critical path initiative and its influence on new drug development.
@nl
type
label
The FDA critical path initiative and its influence on new drug development.
@ast
The FDA critical path initiative and its influence on new drug development.
@en
The FDA critical path initiative and its influence on new drug development.
@nl
prefLabel
The FDA critical path initiative and its influence on new drug development.
@ast
The FDA critical path initiative and its influence on new drug development.
@en
The FDA critical path initiative and its influence on new drug development.
@nl
P1476
The FDA critical path initiative and its influence on new drug development
@en
P2093
Janet Woodcock
P356
10.1146/ANNUREV.MED.59.090506.155819
P577
2008-01-01T00:00:00Z