4.5 Review

Advancing structured decision-making in drug regulation at the FDA and EMA

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Review Pharmacology & Pharmacy

Luxturna: FDA documents reveal the value of a costly gene therapy

Jonathan J. Darrow

DRUG DISCOVERY TODAY (2019)

Editorial Material Medicine, General & Internal

Benefit-Risk Assessments at the US Food and Drug Administration Finding the Balance

Robert M. Califf

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2017)

Article Pharmacology & Pharmacy

Use of multicriteria decision analysis for assessing the benefit and risk of over-the-counter analgesics

Andrew Moore et al.

JOURNAL OF PHARMACY AND PHARMACOLOGY (2017)

Editorial Material Medicine, General & Internal

Approving a Problematic Muscular Dystrophy Drug Implications for FDA Policy

Aaron S. Kesselheim et al.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2016)

Article Public, Environmental & Occupational Health

Recommendations for benefit-risk assessment methodologies and visual representations

Diana Hughes et al.

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY (2016)

Article Public, Environmental & Occupational Health

Cognitive and Motivational Biases in Decision and Risk Analysis

Gilberto Montibeller et al.

RISK ANALYSIS (2015)

Article Public, Environmental & Occupational Health

Modelling the risk-benefit impact of H1N1 influenza vaccines

Lawrence D. Phillips et al.

EUROPEAN JOURNAL OF PUBLIC HEALTH (2013)

Editorial Material Medicine, General & Internal

Surrogate Outcomes in Clinical Trials A Cautionary Tale

Staffan Svensson et al.

JAMA INTERNAL MEDICINE (2013)

Article Peripheral Vascular Disease

Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism

Jose Pablo Morales et al.

Journal of Vascular Surgery-Venous and Lymphatic Disorders (2013)

Editorial Material Medicine, General & Internal

Reputation and Precedent in the Bevacizumab Decision

Daniel Carpenter et al.

NEW ENGLAND JOURNAL OF MEDICINE (2011)

Review Management

Facilitated modelling in operational research

L. Alberto Franco et al.

EUROPEAN JOURNAL OF OPERATIONAL RESEARCH (2010)

Editorial Material Pharmacology & Pharmacy

Measuring Benefit and Balancing Risk: Strategies for the Benefit-Risk Assessment of New Medicines in a Risk-Averse Environment

S. Walker et al.

CLINICAL PHARMACOLOGY & THERAPEUTICS (2009)

Editorial Material Medicine, General & Internal

Safe Drugs and the Cost of Good Intentions

Hans-Georg Eichler et al.

NEW ENGLAND JOURNAL OF MEDICINE (2009)