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AIDS Research Alliance of America focused its research and development program on several core areas, including the clinical trials of anti-HIV drugs that inhibited the virus in novel ways, and new medical strategies – like microbicides and vaccines – that prevented the spread of HIV. [19]
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Decentralized Trials & Research Alliance (DTRA) is a 501(c)(3) nonprofit organization in the United States that works to accelerate the adoption of patient-focused, decentralized trials and research within life sciences and healthcare through education and research. DTRA works to make research participation accessible to everyone, enabled by ...
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
Some two-thirds of candidate drugs fail in Phase 2 clinical trials due to the drug not being as effective as anticipated. Phase 3: The drug is typically tested in several hundred to several thousand people with the targeted disease in double-blind, placebo controlled trials to demonstrate its specific efficacy. Under 30% of drug candidates ...
The logo of the Drugs for Neglected Diseases initiative (DNDi) The Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients' needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for neglected diseases, notably leishmaniasis, sleeping sickness (human African trypanosomiasis, HAT), Chagas disease, [1] malaria, filarial ...
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
Critical Path Institute (C-Path) is a non-profit organization created to improve the drug development process; its consortia include more than 1,600 scientists from government regulatory and research agencies, academia, patient organizations, and bio-pharmaceutical companies.