Dictionary of Pharmaceutical Medicine by Dr. med. Dr. phil. Gerhard Nahler (auth.)

By Dr. med. Dr. phil. Gerhard Nahler (auth.)

The dictionary includes a variety of phrases more often than not utilized in pharmaceutical medication. The 2d version displays the expanding significance of this technological know-how and the altering regulatory setting particularly on study and improvement of latest treatments in addition to at the behavior of medical trials, advertising and marketing authorisation of latest medicinal items and protection facets together with pharmacovigilance.

The variety of keyword phrases has been significantly enlarged and elevated to over 1,600 phrases; it comprises new clinical components reminiscent of gene treatment and proteomics. additionally, given the significance of the net, the hot version includes a checklist of most crucial websites. just like the first version, additionally the ebook explains approximately 1,000 abbreviations most typically utilized in pharmaceutical medicine.

This booklet should be a priceless device for pros within the region of the pharmaceutical undefined, scientific and pre-clinical study, regulatory affairs, advertising and advertising authorisation of pharmaceuticals.

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Extra resources for Dictionary of Pharmaceutical Medicine

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Overview of the therapeutic indication(s), target product profile, profile of competitive drugs, properties of the new substance, justification for development, overview of principle clinical trials with design and size, drug supplies, staffing requirements and financial resources; → see study list. h. ” clinical investigation → see clinical trial. clinical program outline → see study list. clinical research assistant (CRA) → see clinical research associate. clinical research associate (CRA) syn.

G. g. /e. of weight loss programs, cost of means of avoiding an infant death per year of life gained); most appropriate for comparison of treatments not producing an equivalent likelihood of clinical outcome; cost/effectiveness data cos 42 cos are increasingly used to facilitate regulatory approval, justify pricing and influence reimbursement; Australia and Canada request economic data to support product application and reimbursement listing since 1993, in France CEA and quality of life data are explicit criteria for determining prices and reimbursement; it is likely that other European authorities will follow; → see also economic analysis, effectiveness.

Clinical trial (CT) syn. ) or retrospective (historical control, casecontrol study, cross-sectional study); activities concerning CTs are usually divided into 4 stages: a planning or set-up phase, requiring about a few weeks to several months for protocol and case record form preparation, packaging, labelling and regulatory review incl. by an ethical committee, a patient treatment or monitoring phase (including follow-up) and finally the analysis as well as the reporting phase, requiring also a few weeks to several months for data clean-up, quality assurance, statistical analysis and report writing; → see also design, medical office trial, megatrial, multicentre trial, non-alpha site, postmarketing surveillance, run-in phase.

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