Study Methodology

Many of the questions in the survey forms are of a stated-preference nature. In some of these questions, respondents were asked to choose one answer from a given list. In some other questions, respondents were requested to choose all applicable answers from a given list. In the analysis of the results of the former set of questions, the authors will refer to the answers in terms of number of respondents, with the total number of respondents equal to the sample size. However, in the analysis of the second set of questions, the authors will refer to the answers in terms of nmn-ber of responses, which exceeds the sample size. 

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RSSMAP - Reactor Safety Study Methodology Applications Program. 

Gottlieb K, Manchester DK. Twin study methodology and variability in xeno-biotic placental metabolism. Teratog Carcinog Mutagen 1986 6 253-263. 

Study Methodology. The study leader (who bears a lot of responsibility) divides the process into a series of blocks or sections. Each section is then subjected to a brainstorming exercise when the team ponders issues of (essentially) fire, explosion, toxic release and mechanical energy release, how they might arise and the control measures required either to stop the event or cater for its consequences. The starting point for the examination of each section is a prompt from the table below. 

PCR testing, etc. GLPs with the exception of. .. of the toxicology study Methodology/standardization of assays evolving (level of sensitivity improving) Pre-GMP test material Laboratory procedures draft SOPs QA review of the final report only... 

The report of a carcinogenicity study is composed in a similar manner as described for sub-acute to chronic studies. Methodologies, results in a summarized form, individual results have to be the content of a study report which consists of several thousand pages. 

The purpose of this present chapter is to critically discuss study methodologies used to derive quantitative estimates of exposure associated with the mixing, loading and application of pesticides for agricultmal, residential and institutional... 

Although some adverse drug reactions are minor and resolve without sequelae/ others can cause permanent disability or death. ADRs occur commonly/ but estimates of incidence vary considerably. This is due to substantial underreporting of ADRs and differences in study methodology/ populations studied/ and ADR definitions. Adverse drug reactions account for 2.9-15.4% of all hospital admissions in the... 

Zinc gluconate in the form of a lozenge has been marketed for the treatment of the common cold there has been no definitive conclusion as to whether it is effective in treating cold symptoms, although differences in study methodology may partially explain the conflicting results that have been reported... 

All direct and indirect comparisons must not mislead, and be supported by reliable current data. Disclosure of study parameters The claim should be accompanied in prominent type size (a minimum of 8 point on 9 point) by disclosure of relevant study parameters that would aid the reader in interpreting the data, e.g. study methodology, description of patient type and number, disease severity, dosage range, p value or confidence intervals, study sites. In no circumstances would extrapolation of the claim beyond the actual conditions of the supporting studies be acceptable. 

In general, study sites should be visited by a monitor at least every four to six weeks. The frequency of monitoring visits will be defined for each individual study and will depend on details such as the study phase, treatment interval and overall duration, enrolment rate, complexity of the study methodology, occurrence of adverse events (AEs) or other significant events, and the nature of the... 

Arthritis causing inflammatory and degenerative changes around joints affects 43 million in the United States, and CDC projects that this will rise to 60 million by 2020. It can be caused by more than 100 different diseases, but the commonest are osteoarthritis and rheumatoid arthritis. New medications, such as the anti-tumor necrotic factor a-blockers, raise fresh challenges to clinical study methodology because of limitations on nonclinical toxicity predictors and the application of biologic measurements on a traditional drug appraisal system. 

Scrradell, J. BJornson, D.C. Hartzema, A.G. Drug utilization study methodologies National and international perspectives. Drug Intcll. Clin. Pharm. 1987, 21 (12), 994 1001. 

Three landmark placebo-controlled clinical trials have established the benefits of both hypertension treatment and diuretic therapy. The Systolic Hypertension in the Elderly Program (SHEP), the Swedish Trial in Old Patients with Hypertension (STOP-Hypertension), and the Medical Research Council (MRC) trial " showed significant reductions in stroke, myocardial infarction, and aU-cause cardiovascular disease and mortality with thiazide diuretic-based therapy versus placebo. These trials allowed for /3-blockers as add-on therapy for BP control. Newer agents (i.e., ACE inhibitors, angiotensin II receptor blockers [ARBs], and calcium channel blockers [CCBs]) were not available at the time of these studies. However, subsequent clinical trials have compared these newer antihypertensive agents (ACE inhibitors, ARBs, and CCBs) to diuretics." These data show similar effects, but most trials used a prospective, open-label, blinded end point (PROBE) study methodology that is... 

Topics for discussion at advisory committee meetings can run from technical questions about study methodology, to interpretation or adequacy of data, to potential changes in proposed labeling, to an overall assessment of a potentially controversial drug s net benefits (221, 467). Committees may recommend approval, re-analysis of the data, further studies, or rejection of the application, Because these committees reviews are purely advisory and not mandated by law, FDA staff need not follow their recommendations. To date, however, they almost always have done so. 

Cyclic P-diketones and their derivatives have also been the subject of aza-annulation studies. Methodology studies with enamine derivative 171 established the effectiveness of acryloyl chloride (64) for the formation of 172 (eq. 39).56 Aza-annulation with a p-substituted acrylate derivative was most efficiently accomplished through the use of diester Michael acceptors, as exemplified by reaction of 173 with 174 in the generation of 175 (eq. 40).63... 

Important efforts are made to develop economically feasible in vitro culture techniques. It is important to study methodologies which ensure... 

There are two different extensively studied methodologies that have not only put forward logical explanations but also expatiated the highly complicated cardinal factors that essentially govern the molecular modeling phenomenon, namely ... 

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