Disclosure of Clinical Trial Data: Why Exemption 4 of the Freedom of Information Act Should Be Restored [PDF]
, 2005 Clinical trial data generated during the FDA drug approval process can be very valuable. While patients and doctors desperately need this information to make informed choices about medical treatment, drug sponsors strive to keep this resource secret to ...
Boyce, Janene
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Central Asian Journal of Medical Hypotheses and Ethics, 2023 ACTH is a pituitary hormone important for proper function of adrenal glands, cortisol production as well as human physiology in general. It is involved in the pathogenesis of several endocrine disorders like Cushing syndrome and can be a useful ...
George Iliopoulos, Dimitrios Daoussis
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Deep Graph Convolutional Network and LSTM based approach for predicting drug-target binding affinity [PDF]
arXiv, 2022 Development of new drugs is an expensive and time-consuming process. Due to the world-wide SARS-CoV-2 outbreak, it is essential that new drugs for SARS-CoV-2 are developed as soon as possible. Drug repurposing techniques can reduce the time span needed to develop new drugs by probing the list of existing FDA-approved drugs and their properties to reuse
arxiv
United States FDA drug approvals are persistent and polycyclic: Insights into economic cycles, innovation dynamics, and national policy [PDF]
, 2020 It is challenging to elucidate the effects of changes in external influences (such as economic or policy) on the rate of US drug approvals. Here, a novel approach, termed the Chronological Hurst Exponent (CHE), is proposed, which hypothesizes that changes in the long-range memory latent within the dynamics of time series data may be temporally ...
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Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries
Revista Panamericana de Salud Pública, 2021 Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries’ regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are ...
Carlos E. Durán +6 more
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DCcov: Repositioning of Drugs and Drug Combinations for SARS-CoV-2 Infected Lung through Constraint-Based Modelling [PDF]
, 2021 The 2019 coronavirus disease (COVID-19) became a worldwide pandemic with currently no effective antiviral drug except treatments for symptomatic therapy. Flux balance analysis is an efficient method to analyze metabolic networks. It allows optimizing for a metabolic function and thus e.g., predicting the growth rate of a specific cell or the production
arxiv +1 more source
Journal of the American Heart Association : Cardiovascular and Cerebrovascular Disease, 2020 Background In 1993, the US Food and Drug Administration established guidelines to increase diversity by sex and race/ethnicity of participants in clinical trials supporting novel drug approvals.
M. Khan +7 more
semanticscholar +1 more source
The challenges of access to innovative medicines with limited evidence in the European Union
Frontiers in Pharmacology, 2023 The European Medicines Agency (EMA) fosters access to innovative medicines through accelerated procedures and flexibility in the authorization requirements for diseases with unmet medical needs, such as many rare diseases as well as oncological diseases.
Antonio Vallano +7 more
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NeuroCADR: Drug Repurposing to Reveal Novel Anti-Epileptic Drug Candidates Through an Integrated Computational Approach [PDF]
arXiv, 2023 Drug repurposing is an emerging approach for drug discovery involving the reassignment of existing drugs for novel purposes. An alternative to the traditional de novo process of drug development, repurposed drugs are faster, cheaper, and less failure prone than drugs developed from traditional methods.
arxiv
The Impasse on Overall Survival in Oncology Reimbursement Decision-Making: How Can We Resolve This?
Cancer Management and Research, 2021 Michael Patrick Lux, 1 Oriana Ciani, 2 William CN Dunlop, 3 Andrea Ferris, 4 Michael Friedlander 5 1Department of Gynecology and Obstetrics, Frauenklinik St. Louise Paderborn, St. Josefs-Krankenhaus Salzkotten, Frauen- und Kinderklinik St.
Lux MP +4 more
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