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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.
The book was distributed for free to all licensed medical doctors in America; only drugs which drug manufacturers paid to appear, appeared in the PDR, and no generic drugs were listed. The 71st Edition, published in 2017, was the final hardcover edition, weighed in at 4.6 pounds (2.1 kg) and contained information on over 1,000 drugs. [ 1 ]
Beta blockers exert their pharmacological effect, decreased heart rate, by binding to and competitively antagonising a type of receptor called beta adrenoceptors. [1]In pharmacology, the term mechanism of action (MOA) refers to the specific biochemical interaction through which a drug substance produces its pharmacological effect. [2]
The New Zealand Customs Service said that the seized drugs would have been worth up to NZ$3.8 million (about $2.2 million USD) in street value and had a potential social harm cost of approximately ...
It is the study of the workings of a drug on a minimal multicellular system (mMCS), both in vivo and in silico. Networked Multicellular Pharmacodynamics (Net-MCPD) further extends the concept of MCPD to model regulatory genomic networks together with signal transduction pathways, as part of a complex of interacting components in the cell.