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For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
Phase refers to the four phases of clinical research and development: I – small safety trials early on in a drug's development; II – medium-sized trials for both safety and efficacy; III – large trials, which includes key (or so-called "pivotal") trials; IV – large, post-marketing trials, typically for safety reasons. There are also ...
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 ...
The drug pipeline is also sometimes restricted to a particular drug class or extended to mean the process of discovering drugs (the research and development pipeline). [3] The R&D pipeline involves various phases that can broadly be grouped in 4 stages: discovery, pre-clinical, clinical trials and marketing (or post-approval).
Clinical research is different from clinical practice: in clinical practice, established treatments are used to improve the condition of a person, while in clinical research, evidence is collected under rigorous study conditions on groups of people to determine the efficacy and safety of a treatment.
Drug development – the process of taking a new chemical through the stages necessary to allow testing in clinical trials; Biotechnology – the technological application that uses biological systems, living organisms to make or modify products or processes for specific use Biopharmaceutical – a drug produced using biotechnology
times of physiological development can lead to long-lasting health problems, dysfunction, and disease.2 Children’s lung functioning is not yet fully developed.3–5 Compared to adults, they breathe in greater levels of polluted air relative to their weight and spend more time outside when air pollution levels are the highest.5 And
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost.