Hakutulokset: Kirjoja kirjailijalta Development Forum on Drug Discovery
yhteensä 61 hakutulosta
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 …
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, …
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 …
International Regulatory Harmonization Amid Globalization of Drug Development
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, …
Rapid Medical Countermeasure Response to Infectious Diseases
Emerging infectious disease threats that may not have available treatments or vaccines can directly affect the security of the world's health since these diseases also know no …
Challenges for the FDA
As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most …
Direct-to-Consumer Genetic Testing
Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and …
Global Crisis of Drug-Resistant Tuberculosis and Leadership of China and the BRICS
Multidrug-resistant tuberculosis (TB) is caused by bacteria resistant to isoniazid and rifampicin, the two most effective first-line anti-TB drugs, originally developed and …
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 …
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 …
Envisioning a Transformed Clinical Trials Enterprise in the United States
There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is …
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 …