A Guide to Clinical Drug Research
Adam Cohen, John Posner
Kluwer Academic Publishers, 1995 - Medical - 202 pages
A Guide to Clinical Drug Research provides practical advice, from the conception of an idea, planning a study and writing a protocol, through to the conduct of a study, data collection and analysis, and publication. It tells investigators what information they should expect sponsoring companies to provide, particularly when there is only limited information available about a new drug. It also explains what the company can expect of investigators, including the requirements of good clinical practice'. Unlike other currently available texts on clinical trials and pharmaceutical medicine, A Guide to Clinical Drug Research concentrates on the needs of the practising clinician and research team. It is not restricted to drug investigation, and is relevant to all those involved in clinical research in a variety of settings. Audience: Required reading for clinical researchers and others involved as investigators in a drug project, often sponsored by a pharmaceutical company, plus agents of the sponsoring companies themselves.
What people are saying - Write a review
We haven't found any reviews in the usual places.
Facilities and equipment
What does the investigator need to know about the drug?
The first administration of a new active substance to humans
11 other sections not shown
Other editions - View all
active administration adverse events adverse experience agonist appropriate assessment backup bioavailability Chapter Clinical Practice Clinical Practice guidelines clinical research clinical study clinical trial conducted criteria database detail developing countries disease diskettes document effects efficacy electrocardiogram ensure equipment Ethics Committee example files GlaxoWellcome Graphical User Interface guidelines hard disk hardware healthy volunteers hospital idea important individual informed consent Institutional Review Board investigator investigator's Investigator's Brochure involved journal laboratory Laserjet measure metabolism metabolites monitor myocardial infarction number of subjects objectives operating system organisation paper parallel port participation patients performed pharmaceutical company pharmacodynamic pharmacokinetics pharmacology Phase physicians placebo plasma concentration possible printer procedures protocol randomisation record recruitment regulatory repeat dose report form response risk safety samples specific sponsor staff standard study drug summary toxicity toxicology treatment usually write