Results 11 to 20 of about 104,914 (293)
Ethics framework for treatment use of investigational drugs
Background Expanded access is the use of investigational drugs (IDs) outside of clinical trials. Generally it is performed in patients with serious and life-threatening diseases who cannot be treated satisfactorily with authorized drugs.
Jan Borysowski, Andrzej Górski
doaj +1 more source
Drug Repurposing Screen for Compounds Inhibiting the Cytopathic Effect of SARS-CoV-2
Drug repurposing is a rapid approach to identify therapeutics for the treatment of emerging infectious diseases such as COVID-19. To address the urgent need for treatment options, we carried out a quantitative high-throughput screen using a SARS-CoV-2 ...
Catherine Z. Chen +18 more
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Providing Hope: Developing a Viable Regulatory Framework for Providing Terminally Ill Patients With Adequate Access to Investigational Drugs [PDF]
“If I die . . . I want my children to know I did everything I could.” This is a common feeling among terminally ill individuals facing death. This desire to exhaust every option often causes people to fight to receive potentially toxic and dangerous ...
Sikora, James P.
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The need for increased access to investigational drugs has consistently been supported by the public, in spite of the fact that the Expanded Access Program (EAP), which is regulated by the Food and Drug Administration (FDA), already exists.[1] As a ...
Jacqueline Augenstein
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New Strategies for the Treatment of Atrial Fibrillation
Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia in the clinical practice. It significantly contributes to the morbidity and mortality of the elderly population. Over the past 25–30 years intense effort in basic research has advanced the
Norbert Jost +2 more
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Ustekinumab for the treatment of psoriatic arthritis: an update. [PDF]
Psoriatic arthritis occurs in 30% of psoriasis patients, and the treatment can be challenging in some patients. Recently, the US Food and Drug Administration approved ustekinumab, a fully human monoclonal antibody, for the management of psoriatic ...
Davari, Parastoo +3 more
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Diagnosis and Management of COVID-19 Disease [PDF]
SARS-CoV-2 is a novel coronavirus that was identified in late 2019 as the causative agent of COVID-19 (aka coronavirus disease 2019). On March 11, 2020, the World Health Organization (WHO) declared the world-wide outbreak of COVID-19 a pandemic.
Carlos, Graham +5 more
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An analysis of common ethical justifications for compassionate use programs for experimental drugs [PDF]
BACKGROUND: When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years.
Raus, Kasper
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Introduction: Physicians in the United States play an essential role guiding patients through single patient pre-approval access (PAA) to investigational medical products via either the Food and Drug Administration (FDA)’s Expanded Access (EA) or the ...
Carolyn Riley Chapman +4 more
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Investigational new drugs for focal epilepsy. [PDF]
For more than 30 years, antiepileptic drug development has been based on specific assumptions regarding the neurobiology of epilepsy but all marketed drugs have not changed the proportion of drug refractory patients.
Mula, M
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