Review of investigational drugs for coronavirus disease 2019 [PDF]
Journal of Education and Health Promotion, 2021 In December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became evident in Wuhan, China, and then spread rapidly worldwide.
Dhruva Sharma +3 more
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Ethics framework for treatment use of investigational drugs [PDF]
BMC Medical Ethics, 2020 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
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Medical Management of Pulmonary Arterial Hypertension: Current Approaches and Investigational Drugs [PDF]
Pharmaceutics, 2023 Pulmonary arterial hypertension (PAH) is a malignant pulmonary vascular syndrome characterized by a progressive increase in pulmonary vascular resistance and pulmonary arterial pressure, which eventually leads to right heart failure and even death ...
Qi Jin +9 more
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Expanding Patient Access to Investigational Drugs [PDF]
JACC: Basic to Translational Science, 2018 Summary: With drug approval times taking an average of 8 years from entry into clinical trials to full U.S. Food and Drug Administration (FDA) approval, patients with life-threatening and severely debilitating disease and no reasonable therapeutic ...
Gail A. Van Norman, MD
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Current and investigational drugs in early clinical development for portal hypertension [PDF]
Frontiers in Medicine, 2022 IntroductionThe development of portal hypertension leads to a majority of complications associated with chronic liver disease. Therefore, adequate treatment of portal hypertension is crucial in the management of such patients.
Sasan Sakiani +2 more
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Standard care and investigational drugs in the treatment of myelofibrosis [PDF]
Drugs in Context, 2019 Myelofibrosis (MF) is a heterogeneous disorder characterized by splenomegaly, constitutional symptoms, ineffective hematopoiesis, and an increased risk of leukemic transformation.
Daniela Barraco +2 more
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Evaluation of the prescribed drugs to elderly in a tertiary healthcare center for possible drug interactions with investigational drugs for covid-19 treatment [PDF]
Journal of Research in Pharmacy Practice, 2020 Objective: Earlier identifying drug interactions may help in risk reduction in elderly patients. Methods: Drug prescription data of 212 elderly patients of tertiary health care center had been analyzed for possible drug interactions with investigational ...
Yogendra Keche +3 more
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The changing landscape of expanded access to investigational drugs for patients with unmet medical needs: ethical implications [PDF]
Journal of Pharmaceutical Policy and Practice, 2017 When patients are told that standard medical treatment options have been exhausted, their treating physicians may start looking for promising new drugs that are not yet approved, and still under investigation.
Eline M. Bunnik +2 more
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PLoS ONE, 2021 The U.S. Food and Drug Administration (FDA) allows patients with serious illnesses to access investigational drugs for "compassionate use" outside of clinical trials through expanded access (EA) Programs.
Jeremiah Stout +6 more
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Humanities & Social Sciences Communications, 2021 Seriously ill patients who have exhausted all approved treatment regimens and who cannot be enrolled in clinical trials may resort to expanded access programmes in order to gain access to unapproved, investigational drugs. It seems that in some countries,
Stefan F. Vermeulen +3 more
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