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Pamrevlumab (INN; [1] development code FG-3019) is a humanized monoclonal antibody designed for the treatment of idiopathic pulmonary fibrosis and pancreatic cancer. It binds to the connective tissue growth factor (CTGF) protein.
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.
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may ...
By David Bautz, PhD NASDAQ:EPIX READ THE FULL EPIX RESEARCH REPORT Business Update Additional Preclinical Data Presented at AACR 2021 On April 10, 2021, ESSA Pharma, Inc. (NASDAQ:EPIX) announced ...
The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
Accurate computer models of a treatment and its deployment, as well as patient characteristics, are necessary precursors for the development of in silico clinical trials. [5] [6] [8] [9] In such a scenario, ‘virtual’ patients would be given a ‘virtual’ treatment, enabling observation through a computer simulation of how the candidate biomedical product performs and whether it produces ...
Often, a clinical trial management system provides data to a business intelligence system, which acts as a digital dashboard for trial managers. [5] [6] [7] CTMSs allow experts easily to access centralized data and thus reducing the number of delayed trials. Sponsors can work with a database of previously researched contacts and names of ...
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices.