FDA: evidentiary standards for drug development and approval.
about
A novel approach to delayed-start analyses for demonstrating disease-modifying effects in Alzheimer's diseaseThe oxidative stress theory of disease: levels of evidence and epistemological aspects.Why do so many drugs for Alzheimer's disease fail in development? Time for new methods and new practices?Estimating sample sizes for predementia Alzheimer's trials based on the Alzheimer's Disease Neuroimaging Initiative.A simulation study of the strength of evidence in the recommendation of medications based on two trials with statistically significant resultsClinical trials in pediatric traumatic brain injury: unique challenges and potential responses.Neuropsychiatric clinical trials: should they accommodate real-world practices or set standards for clinical practices?Magnetic resonance imaging metrics and their correlation with clinical outcomes in multiple sclerosis: a review of the literature and future perspectives.Alzheimer's disease drug development: old problems require new priorities.A new regulatory road-map for Alzheimer's disease drug developmentDisease models for the development of therapies for lysosomal storage diseases.Preclinical Efficacy Failure of Human CNS-Derived Stem Cells for Use in the Pathway Study of Cervical Spinal Cord Injury.Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology.Considerations for the clinical use of contrast agents for cellular MRI in regenerative medicine.Widening the path and window of opportunity for FDA approval of non-vitamin K oral anticoagulant specific antidotes and reversal agents.Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?A new proposal for randomized start design to investigate disease-modifying therapies for Alzheimer disease.Achieving Informed Consent for Cellular Therapies: A Preclinical Translational Research Perspective on Regulations versus a Dose of RealityNew pathways for evaluating potential acute stroke therapies.Rhinosinusitis: Developing guidance for clinical trials.European Marketing Authorizations Granted Based on a Single Pivotal Clinical Trial: The Rule or the Exception?Delayed-start analysis: Mild Alzheimer's disease patients in solanezumab trials, 3.5 years.A side-effect free method for identifying cancer drug targets.Cognitive composite score association with Alzheimer's disease plaque and tangle pathology
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P2860
FDA: evidentiary standards for drug development and approval.
description
2004 nî lūn-bûn
@nan
2004年の論文
@ja
2004年論文
@yue
2004年論文
@zh-hant
2004年論文
@zh-hk
2004年論文
@zh-mo
2004年論文
@zh-tw
2004年论文
@wuu
2004年论文
@zh
2004年论文
@zh-cn
name
FDA: evidentiary standards for drug development and approval.
@ast
FDA: evidentiary standards for drug development and approval.
@en
type
label
FDA: evidentiary standards for drug development and approval.
@ast
FDA: evidentiary standards for drug development and approval.
@en
prefLabel
FDA: evidentiary standards for drug development and approval.
@ast
FDA: evidentiary standards for drug development and approval.
@en
P2860
P356
P1433
P1476
FDA: evidentiary standards for drug development and approval.
@en
P2093
Russell Katz
P2860
P304
P356
10.1602/NEURORX.1.3.307
P577
2004-07-01T00:00:00Z