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Pivotal Phase III trials assess whether a candidate drug has efficacy specifically against a disease, and – in the case of people hospitalized with severe COVID-19 infections – test for an effective dose level of the repurposed or new drug candidate to improve the illness (primarily pneumonia) from COVID-19 infection.
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 ...
Mirikizumab, a drug currently approved by the Food and Drug Administration (FDA) for the treatment of ulcerative colitis, also sends Crohn's disease into clinical remission, new findings suggest.
Drug Design, Development and Therapy; Drug Development and Industrial Pharmacy; Drug Discovery Today; Drug, Healthcare and Patient Safety; Drug Safety; Drug Metabolism Reviews; Drug Testing and Analysis; European Heart Journal - Cardiovascular Pharmacotherapy; European Journal of Pharmaceutical Sciences; European Journal of Pharmaceutics and ...
Pharmaceutical Research is an official journal of the American Association of Pharmaceutical Scientists and covers research spanning the entire spectrum of drug discovery, development, evaluation, and regulatory approval.
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.
Molecular Pharmaceutics is a peer-reviewed scientific journal covering research on the molecular mechanistic understanding of drug delivery and drug delivery systems, including physical and pharmaceutical chemistry, biochemistry and biophysics, molecular and cellular biology, and polymer and materials science.
In the fields of medicine, biotechnology, and pharmacology, drug discovery is the process by which new candidate medications are discovered. [ 1 ] Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery, as with penicillin .