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In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
GS-441524 nucleoside is phosphorylated by nucleoside kinases (probably adenosine kinase (ADK), which is the enzyme that phosphorylates the structurally similar ribavirin), and then phosphorylated again by nucleoside-diphosphate kinase (NDK) to the active nucleotide triphosphate form.
Litifilimab is an investigational drug being evaluated for the treatment of cutaneous lupus erythematosus and systemic lupus erythematosus. It is an anti- BDCA2 monocolonal antibody. [ 1 ] [ 2 ] [ 3 ]
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.
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
Enlicitide chloride (INN; [1] previously known as MK-0616) is a macrocyclic peptide investigational drug that is being evaluated for the treatment of hypercholesterolaemia. It is a PCSK9 inhibitor. [2] Merck has launched a Phase 3 clinical trial to evaluate the efficacy and safety of MK-0616 in Adults With Hypercholesterolemia. [3] [4]
This is a list of investigational hallucinogens and entactogens, or hallucinogens and entactogens that are currently under formal development for clinical use but are not yet approved. [ 1 ] Chemical/generic names are listed first, with developmental code names, synonyms, and brand names in parentheses.
To legally test the drug on human subjects in the United States, the maker must first obtain an Investigational New Drug (IND) designation from FDA. [5] This application is based on nonclinical data, typically from a combination of in vivo and in vitro laboratory safety studies, that shows the drug is safe enough to test in humans. [5]