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  2. Standard for Exchange of Non-clinical Data - Wikipedia

    en.wikipedia.org/wiki/Standard_for_Exchange_of...

    An FDA building. The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development.

  3. SDTM - Wikipedia

    en.wikipedia.org/wiki/SDTM

    SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).

  4. Investigational device exemption - Wikipedia

    en.wikipedia.org/wiki/Investigational_Device...

    An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2 ...

  5. CFR - Code of Federal Regulations Title 21

    highline.huffingtonpost.com/miracleindustry/...

    the application. To the extent possible, data in the summary should be presented in tabular and graphic forms. FDA has prepared a guideline under 10.90(b) that provides information about how to prepare a summary. The summary required under this paragraph may be used by FDA

  6. New Drug Application - Wikipedia

    en.wikipedia.org/wiki/New_Drug_Application

    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]

  7. Good laboratory practice - Wikipedia

    en.wikipedia.org/wiki/Good_Laboratory_Practice

    The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]

  8. Stealth BioTherapeutics Showcases New Nonclinical Data From ...

    www.aol.com/news/stealth-biotherapeutics...

    The data were presented at the 2022 Muscular Dystrophy Association and Clinical and Scientific Conference. Mitochondrial dysfunction has been observed early in the progression of Duchenne muscular ...

  9. Preclinical development - Wikipedia

    en.wikipedia.org/wiki/Preclinical_development

    In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.