Pain management and the opioid epidemic: balancing societal and individual benefits and risks of prescription opioid use
JK Phillips, MA Ford, RJ Bonnie - 2017 - books.google.com
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading
cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the …
cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the …
Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy
DT Michaeli, T Michaeli, S Albers, T Boch… - The European Journal of …, 2024 - Springer
Background Over the past decades, US Congress enabled the US Food and Drug
Administration (FDA) to facilitate and expedite drug development for serious conditions …
Administration (FDA) to facilitate and expedite drug development for serious conditions …
FDA approval and regulation of pharmaceuticals, 1983-2018
Importance US law requires testing of new drugs before approval to ensure that they provide
a well-defined benefit that is commensurate with their risks. A major challenge for the US …
a well-defined benefit that is commensurate with their risks. A major challenge for the US …
Failure of investigational drugs in late-stage clinical development and publication of trial results
TJ Hwang, D Carpenter, JC Lauffenburger… - JAMA internal …, 2016 - jamanetwork.com
Importance Many investigational drugs fail in late-stage clinical development. A better
understanding of why investigational drugs fail can inform clinical practice, regulatory …
understanding of why investigational drugs fail can inform clinical practice, regulatory …
[图书][B] Deadly medicines and organised crime: how big pharma has corrupted healthcare
P Gotzsche - 2019 - taylorfrancis.com
PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART
DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the …
DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the …
Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010
NS Downing, ND Shah, JA Aminawung, AM Pease… - Jama, 2017 - jamanetwork.com
Importance Postmarket safety events of novel pharmaceuticals and biologics occur when
new safety risks are identified after initial regulatory approval of these therapeutics. These …
new safety risks are identified after initial regulatory approval of these therapeutics. These …
[图书][B] The evolving threat of antimicrobial resistance: options for action
World Health Organization - 2012 - apps.who.int
国家の医療費に余裕がない大幅な財政負担に加えて, 抗菌薬耐性は耐性菌感染の国境を越えた
国際的な移動や貿易に悪い影響となるように, 医療部門を超えて経済的影響を持ちつつあります …
国際的な移動や貿易に悪い影響となるように, 医療部門を超えて経済的影響を持ちつつあります …
Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study
Objective To evaluate the use of special expedited development and review pathways at the
US Food and Drug Administration over the past two decades. Design Cohort study. Setting …
US Food and Drug Administration over the past two decades. Design Cohort study. Setting …
Adaptive licensing: taking the next step in the evolution of drug approval
HG Eichler, K Oye, LG Baird, E Abadie… - Clinical …, 2012 - Wiley Online Library
Traditional drug licensing approaches are based on binary decisions. At the moment of
licensing, an experimental therapy is presumptively transformed into a fully vetted, safe …
licensing, an experimental therapy is presumptively transformed into a fully vetted, safe …
Demythologizing the high costs of pharmaceutical research
DW Light, R Warburton - BioSocieties, 2011 - Springer
It is widely claimed that research to discover and develop new pharmaceuticals entails high
costs and high risks. High research and development (R&D) costs influence many decisions …
costs and high risks. High research and development (R&D) costs influence many decisions …