A Guide to Clinical Drug Research
A. Cohen, J. Posner
Springer Science & Business Media, Apr 30, 2000 - Medical - 206 pages
Following the success of the first edition, published in 1995, this fully rewritten A Guide to Clinical Drug Research - Second Edition has been adapted to the most recent guidelines and developments in the field. It continues to provide a wealth of practical advice, ranging 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 pharmacuetical company, plus agents of the sponsoring companies themselves.
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From idea to publication
Facilities and Equipment
know about the drug? the Clinical Investigators Brochure
substance to humans
Planning and coordinating the study
The study protocol
Other editions - View all
active agonist animals appropriate assessment blood pressure Carcinogenicity Chapter clinical drug research Clinical Practice clinical research clinical study clinical trial conducted consent form criteria cross-over database defined developing countries disease document drug development effects efficacy electrocardiogram endpoint ensure Ethics Committee evaluation example exposure guidelines haematology healthy volunteers hospital human subjects idea important individual informed consent Institutional Review Board investigational product investigator Investigator's Brochure involved journal laboratory measurements medicine metabolites monitor myocardial infarction number of subjects objectives organisation paper participation patients performed pharmaceutical company pharmacodynamic pharmacokinetics pharmacology Phase physicians placebo plasma concentrations population possible potential procedures records recruitment regulatory authorities relevant repeated dose studies report form response risk safety scientific serious adverse event specific sponsor staff standard statistical analysis study drug study protocol summary tests therapeutic toxicity toxicology treatment usually write