Sökt på: Böcker av Development Forum on Drug Discovery
totalt 62 träffar
Large Simple Trials and Knowledge Generation in a Learning Health System
Randomized clinical trials (RCTs) are often referred to as the "e;gold standard"e; of clinical research. However, in its current state, the U.S. clinical trials enterprise …
Public Engagement and Clinical Trials
Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to …
Accelerating the Development of Biomarkers for Drug Safety
Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing …
Addressing the Barriers to Pediatric Drug Development
Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to …
Adverse Drug Event Reporting
Recent concerns about the unexpected adverse effects of marketed drugs, such as COX-2 (cyclooxygenase-2) inhibitors or specific statins, raise concerns not only about reporting …
Innovation in Drug Research and Development for Prevalent Chronic Diseases
Investment and innovation in drug research and development (R&D) for highly prevalent chronic diseases has stalled in recent decades, despite half of all Americans living with at …
Advancing Regulatory Science for Medical Countermeasure Development
Whether or not the United States has safe and effective medical countermeasures--such as vaccines, drugs, and diagnostic tools--available for use during a disaster can mean the …
Large Simple Trials and Knowledge Generation in a Learning Health System
Randomized clinical trials (RCTs) are often referred to as the "e;gold standard"e; of clinical research. However, in its current state, the U.S. clinical trials enterprise …
Emerging Safety Science
In recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, …
Virtual Clinical Trials
Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the …
Inclusion of Pregnant and Lactating Persons in Clinical Trials
Approximately 4 million pregnant people in the United States give birth annually, and 70 percent of these individuals take at least one prescription medication during their …
Advancing the Discipline of Regulatory Science for Medical Product Development
The field of endeavors known as regulatory science has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical …