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The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare,made to enable information system interoperability and to improve medical research and related areas of healthcare.
The Interventions class captures investigational treatments, therapeutic treatments, and surgical procedures that are intentionally administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., “exposure”), coincident with the study assessment period (e.g., “concomitant ...
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.
Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards.
For example, an electronic evidence-based medicine system may potentially consider a patient's symptoms, medical history, family history and genetics, as well as historical and geographical trends of disease occurrence, and published clinical data on therapeutic effectiveness when recommending a patient's course of treatment.
Therapeutic drug monitoring (TDM) is a branch of clinical chemistry and clinical pharmacology that specializes in the measurement of medication levels in blood. Its main focus is on drugs with a narrow therapeutic range , i.e. drugs that can easily be under- or overdosed. [ 1 ]
Therapeutic Target Database (TTD) is a pharmaceutical and medical repository [1] constructed by the Innovative Drug Research and Bioinformatics Group (IDRB) at Zhejiang University, China and the Bioinformatics and Drug Design Group at the National University of Singapore.
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