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The American Statistical Association and DIA have created an interdisciplinary working group of drug safety experts from academia, industry and regulatory backgrounds to explore the future direction for safety monitoring. This introduction to the series explains the background and rationale for this special section.
This article was published in the following journal.
Name: Therapeutic innovation & regulatory science
The safety and efficacy of a hemostatic powder (HP) versus a control agent, absorbable gelatin sponge and thrombin (G + T), were assessed, using a validated, quantitative bleeding severity scale.
Intussusception is the invagination of one segment of the bowel into a distal segment, characterized by symptoms of bloody stool, vomiting, and abdominal pain. Previous studies have found regional dif...
Proper food safety training is essential to decrease incidences and overall rates of foodborne illnesses and outbreaks. Though many commercial restaurants should provide proper food safety training to...
Multimodal monitoring (MMM) is used frequently to guide care of patients with severe acute brain injury. In this study we examined the safety and reliability of multimodality monitoring.
The Checkpoint nerve stimulator (Checkpoint Surgical, Cleveland, OH) is a U.S. Food and Drug Administration-approved device for neural localization and monitoring during surgery. Its safety, efficacy,...
The aim of the research study will be assess the effectiveness of a long-term interdisciplinary lifestyle in many aspects including food intake, psychological symptoms, physical activity h...
The impact of rotavirus vaccination on the burden of disease has been well documented. However, the anticipated reduction in hospital pressures has yet to be described. This study will pro...
Almost all people who suffer from dementia experience neuropsychiatric symptoms (NPS) in the course of the disease. TIME (Targeted Interdisciplinary Model for Evaluation and treatment of n...
Quantitative Sensory Testing (QST) is a novel investigative technique used in other pain conditions to evaluate patterns of chronic pain, and in this study will be used to elucidate pain p...
Current diagnostic tools used in pulmonary disease often do not meet the challenges set by the respective pathophysiology. The investigators therefore aimed to evaluate novel or not widely...
Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.
Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, practicability, etc., of these interventions in individual cases or series.
Activities involved in ensuring the safety of FOOD including avoidance of bacterial and other contamination.
An office in the Department of Labor responsible for developing and establishing occupational safety and health standards.
Measurable biological parameters that serve for drug development, safety and dosing (DRUG MONITORING).
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...