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EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a ...
Statistics in Medicine is a peer-reviewed statistics journal published by Wiley. Established in 1982, the journal publishes articles on medical statistics. The journal is indexed by Mathematical Reviews and SCOPUS. According to the Journal Citation Reports, the journal has a 2023 impact factor of 1.8. [1]
Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (PDF version) (PDF - 165KB) CDRH/CBER, May 2005; Guidance for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use CDRH/CBER, November 2004
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).
The ICMJE recommendations (full title, "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals") are a set of guidelines produced by the International Committee of Medical Journal Editors for standardising the ethics, preparation and formatting of manuscripts submitted to biomedical journals for publication. [1]
The Canadian Journal of Statistics; Communications in Statistics; International Statistical Review; Journal of the American Statistical Association; Journal of Multivariate Analysis; Journal of the Royal Statistical Society; Probability and Mathematical Statistics; Sankhyā: The Indian Journal of Statistics; Scandinavian Journal of Statistics ...
However, "biostatistics" more commonly connotes all applications of statistics to biology. [2] Medical statistics is a subdiscipline of statistics. It is the science of summarizing, collecting, presenting and interpreting data in medical practice, and using them to estimate the magnitude of associations and test hypotheses.