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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 ...
Auxiliary labels stating "take with food or milk" and "do not take with aspirin" Auxiliary labels are small stickers consisting of one or more lines of text intended to enhance patient knowledge, with or without a pictogram. The directions for use included on the standard prescription label are typically limited to direct administration ...
Code of Federal Regulations, Title 21--Food and Drugs, Chapter I--Food and Drug Administration, Department of Health and Human Services, Part 312--Investigational New Drug Application, Subpart A--General Provisions, Sec. 312.3 Definitions and Interpretations, archived from the original on June 26, 2003 ICH E6
A popular example of drug–food interaction is the effect of grapefruit on the metabolism of drugs. Interactions may occur by simultaneous targeting of receptors , directly or indirectly. For example, both Zolpidem and alcohol affect GABA A receptors , and their simultaneous consumption results in the overstimulation of the receptor, which can ...
Pharmacognosy is the study of crude drugs obtained from medicinal plants, animals, fungi, and other natural sources. [1] The American Society of Pharmacognosy defines pharmacognosy as "the study of the physical, chemical, biochemical , and biological properties of drugs, drug substances, or potential drugs or drug substances of natural origin ...
A low drug load may cause homogeneity problems. A high drug load may pose flow problems or require large capsules if the compound has a low bulk density. By the time phase III clinical trials are reached, the formulation of the drug should have been developed to be close to the preparation that will ultimately be used in the market. A knowledge ...
The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II. The drug or other substance has a currently [1] accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
If a patient using an alpha-glucosidase inhibitor suffers from an episode of hypoglycemia, the patient should eat something containing monosaccharides, such as glucose tablets. Since the drug will prevent the digestion of polysaccharides (or non-monosaccharides), non-monosaccharide foods may not effectively reverse a hypoglycemic episode in a ...