about
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need.Rare Cancers Europe (RCE) methodological recommendations for clinical studies in rare cancers: a European consensus position paper.Understanding drug preferences, different perspectives.Blood donor selection in European Union directives: room for improvement.Quantifying benefit-risk preferences for new medicines in rare disease patients and caregivers.Factors influencing quality decision-making: regulatory and pharmaceutical industry perspectives.Emerging drug for diarrhea predominant irritable bowel syndrome.Number needed to harm in the post-marketing safety evaluation: results for rosiglitazone and pioglitazone.A 'Global Reference' Comparator for Biosimilar Development.New insights into the evaluation of randomized controlled trials for rare diseases over a long-term research horizon: a simulation study.Alternative designs for clinical trials in rare diseases.From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.Medical innovation then and now: perspectives of innovators responsible for transformative drugs.A New Paradigm. "Learn - Learn More"; Dose-Exposure-Response at the Center of Drug Development and Regulatory Approval.Active Surveillance versus Spontaneous Reporting for First-Line Antiretroviral Medicines in Namibia: A Cost-Utility Analysis.Sentinel site active surveillance of safety of first-line antiretroviral medicines in Namibia.Why does increasing public access to medicines differ between countries? Qualitative comparison of nine countries.Use of the conditional marketing authorization pathway for oncology medicines in Europe.Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation.Adaptive designs for subpopulation analysis optimizing utility functions.Falsified Medicines-Bridging the Gap between Business and Public Health.The risks of methodology aversion in drug regulation.Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review.Development of a Framework Based on Reflective MCDA to Support Patient-Clinician Shared Decision-Making: The Case of the Management of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) in the United States.Between January 2009 and April 2016, 134 novel anticancer therapies were approved: what is the level of knowledge concerning the clinical benefit at the time of approval?Patient Involvement in the Lifecycle of Medicines According to Belgian Stakeholders: The Gap Between Theory and Practice
P2860
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P2860
description
2013 nî lūn-bûn
@nan
2013年の論文
@ja
2013年学术文章
@wuu
2013年学术文章
@zh-cn
2013年学术文章
@zh-hans
2013年学术文章
@zh-my
2013年学术文章
@zh-sg
2013年學術文章
@yue
2013年學術文章
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2013年學術文章
@zh-hant
name
The risks of risk aversion in drug regulation.
@en
type
label
The risks of risk aversion in drug regulation.
@en
prefLabel
The risks of risk aversion in drug regulation.
@en
P2093
P2860
P356
P1476
The risks of risk aversion in drug regulation.
@en
P2093
Alasdair Breckenridge
Brigitte Bloechl-Daum
Christian K Schneider
Daniel Brasseur
Guido Rasi
Hans-Georg Eichler
Hubert Leufkens
June Raine
Tomas Salmonson
P2860
P2888
P304
P356
10.1038/NRD4129
P577
2013-11-15T00:00:00Z