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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 ...
A Handbook on Drug and Alcohol Abuse: The Biomedical Aspects by Gail Winger, Frederick G. Hofmann, and James H. Woods was published in New York by Oxford University Press in 1992. A 4th edition, updated with a chapter for "Club Drugs", was published in 2004.
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.
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.
Pharmacodynamics (PD) is the study of the biochemical and physiologic effects of drugs (especially pharmaceutical drugs). The effects can include those manifested within animals (including humans), microorganisms , or combinations of organisms (for example, infection ).
Handbook on Drug and Alcohol Abuse; Having a Great Birth in Australia; Healing Words: Poetry and Medicine; How Not to Die: Discover the Foods Scientifically Proven to Prevent and Reverse Disease; How to Eat to Live; The Hundred Year Lie
Pharmacoepidemiology is the study of the uses and effects of drugs in well-defined populations. [1] [2] To accomplish this study, pharmacoepidemiology borrows from both pharmacology and epidemiology. Thus, pharmacoepidemiology is the bridge between both pharmacology and epidemiology.
The action of drugs on the human body (or any other organism's body) is called pharmacodynamics, and the body's response to drugs is called pharmacokinetics. The drugs that enter an individual tend to stimulate certain receptors, ion channels, act on enzymes or transport proteins. As a result, they cause the human body to react in a specific way.