Free Differential Algebras: Their Use in Field Theory and Dual Formulation [PDF]
The gauging of free differential algebras (FDA's) produces gauge field theories containing antisymmetric tensors. The FDA's extend the Cartan-Maurer equations of ordinary Lie algebras by incorporating p-form potentials ($p > 1$).
Alberto Perotto +7 more
core +2 more sources
Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core +3 more sources
Identification of New Drug Candidates Against \u3cem\u3eBorrelia burgdorferi\u3c/em\u3e Using High-Throughput Screening [PDF]
Lyme disease is the most common zoonotic bacterial disease in North America. It is estimated that .300,000 cases per annum are reported in USA alone. A total of 10%–20% of patients who have been treated with antibiotic therapy report the recrudescence of
Babar, Mustafeez Mujtaba +9 more
core +3 more sources
Seeking out non-public information : sell-side analysts and the freedom of information act [PDF]
A number of sell-side healthcare analysts gain access to information outside the purview of management through Freedom of Information Act requests to the Food and Drug Administration for records on factory inspections, complaints, and drug and medical ...
Klein, April, Li, Tao, Zhang, Bobo
core +1 more source
Taking Biologics for Granted? Takings, Trade Secrets, and Off-Patent Biological Products [PDF]
Biologics are complex medicines which are often genetically engineered, and which are sure to play an important role in curing some of humankind\u27s worst diseases. Not surprisingly, generic companies want a part of the biologic market. The FDA believes
Bergman, Karl-Olof +2 more
core +3 more sources
A review of new drugs approved by the food and drug administration in 2022
Introduction: The drugs approved by the Food and Drug Administration (FDA) in 2022, for the first time for any indication or under any brand, were studied under the contexts of indications, mechanism of action, and side effects.
Arjun Swaminathan +2 more
doaj +1 more source
Center for Biologics Evaluation and Research enhances and supports regulatory decision-making and policy development. This work contributes to our regulatory mission, advances medical product development, and supports Food and Drug Administration’s ...
Marc Kusinitz +2 more
doaj +1 more source
SARS-CoV2 infection has been linked to a wide range of clinical severities and the immunopathology is still under intense scrutiny. Here, the authors uncover an association of antibody affinity maturation and plasma IgA levels with clinical outcome in ...
Juanjie Tang +8 more
doaj +1 more source
Reporting bias in drug trials submitted to the Food and Drug Administration: review of publication and presentation. [PDF]
BackgroundPrevious studies of drug trials submitted to regulatory authorities have documented selective reporting of both entire trials and favorable results.
Bacchetti, Peter +2 more
core +3 more sources
Pure Spinors, Free Differential Algebras, and the Supermembrane [PDF]
The lagrangian formalism for the supermembrane in any 11d supergravity background is constructed in the pure spinor framework. Our gauge-fixed action is manifestly BRST, supersymmetric, and 3d Lorentz invariant. The relation between the Free Differential
Aisaka +55 more
core +2 more sources

