English-Russian glossary of clinical practice. 2002.
Trial of Conrad Murray — People v. Murray Court Superior Court of Los Angeles County Full case name People of the State of California v. Conrad Robert Murray Date decided November 7, 2011 Judge(s) sitting Michael E. Pastor Case opinions … Wikipedia
FDA Fast Track Development Program — The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration that accelerates the approval of investigational new drugs undergoing clinical trials. Such status is often given to agents that show… … Wikipedia
FDA Special Protocol Assessment — A Special Protocol Assessment (SPA) is a declaration from the Food and Drug Administration that an uncompleted Phase III trial s design, clinical endpoints, and statistical analyses are acceptable for FDA approval. External links*… … Wikipedia
Clinical trial — Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be… … Wikipedia
Kano Trovafloxacin trial litigation — In 1996 Pfizer conducted tests of the drug trovafloxacin in Nigeria on one hundred children (Source of number: http://www.irinnews.org/PrintReport.aspx?ReportId=72601 link leads to UN IRIN news report), five of whom died. Many others suffered… … Wikipedia
JANUS clinical trial data repository — is a clinical trial data repository (or data warehouse) standard as sanctioned by the Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see… … Wikipedia
Seeding trial — A seeding trial or marketing trial is a form of marketing, conducted in the name of research, designed to target product sampling towards selected consumers. In medicine, seeding trials are clinical trials or research studies where the primary… … Wikipedia
Clinical trial management system — A Clinical Trial Management System, also known as CTMS, is a customizable software system used by the biotechnology and pharmaceutical industries to manage the large amounts of data involved with the operation of a clinical trial. It maintains… … Wikipedia
clinical trial — noun a rigorously controlled test of a new drug or a new invasive medical device on human subjects; in the United States it is conducted under the direction of the FDA before being made available for general clinical use • Syn: ↑clinical test •… … Useful english dictionary
Clinical Trial Management System — A Clinical Trial Management System, also known as CTMS , is a customizeable software system used by the biotechnology and pharmaceutical industries to manage the large amounts of data involved with the operation of a clinical trial. It maintains… … Wikipedia
phase III clinical trial — noun a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA • Syn … Useful english dictionary
