Clinical trials review articles

The review articles by Schramm (1998, 2003) provide a number of examples of the successful application of this protocol to the design of enzyme-specific transition state-like inhibitors. Among these, the transition state inhibitors of human purine nucleoside phosphorylase (PNP) are particularly interesting from a medicinal chemistry perspective, as examples of these compounds have entered human clinical trials for the treatment of T-cell cancers and autoimmune disorders. 

The development of Cat K inhibitors, with an emphasis on the fundamental biology, pharmacology and human clinical trials has been recently reviewed [1-3]. The medicinal chemistry of Cat K inhibitors has also been the subject of recent reviews [7,8]. This article reviews recent publications and meeting abstracts on the design of Cat K inhibitors, as well as developments in Cat K-related biology including animal models for the prediction of inhibitor efficacy, the potential for the separation of bone resorption and formation by Cat K inhibitors, inhibitor selectivity considerations and other potential indications for Cat K inhibitors. 

Confirmatory clinical trials (Phase 111, including published review articles)... 

Most efficacy trials with reboxetine have so far only been published in review articles ( 178). Most of these articles did not have peer review and do not contain the full details concerning methodology or results. This fact limits the ability to accurately determine its relative efficacy and tolerability. In short-term (4 to 8 weeks), placebo-controlled clinical trials, reboxetine produced a response (defined as at least a 50% reduction in severity scores) in 56% to 74% of patients. These results were statistically superior to placebo in most studies. Reboxetine was also found to be as effective as imipramine and desipramine in four double-blind, randomized, active-controlled (but not placebo-controlled) studies involving more than 800 outpatients or inpatients with major depression. Reboxetine produced equivalent antidepressant response rates compared with fluoxetine in two clinical trials, one of which was also placebo-controlled. However, reboxetine was reported to have improved social motivation and behavior more than fluoxetine as assessed by the newly developed Social Adaptation Self-Evaluation Scale. In all of the studies, reboxetine had a similar time (i.e., 2 to 3 weeks) to onset of the antidepressant efficacy as do other antidepressants. 

AV Pollack. Review article controlled clinical trials. Life Support Syst 1 7-233,... 

Although it is best that both the investigator and a physician independent of the clinical trial determine the necessity for emergency use of an investigational product prior to its use, if this is not possible, the investigator must have the determination of use reviewed, evaluated, and submitted to the IRB within five (5) working days after use of the test article. 

Numerous analogs and prodrugs of paclitaxel have been developed, and several of these are in clinical trials. Full coverage of these compounds is beyond the scope of this article, but additional details are provided in a recent review (33). As of early 2007, the only new form of paclitaxel in clinical use is the albumin-bound paclitaxel known as Abraxane (Abraxis BioScience, Schaumberg, IL) (34). 

Of course, published review articles, clinical trials, and case reports can be found on Medline. To aid the pharmacy practitioner in evaluating the potential safety and efficacy of various herbal products, the following is a list of additional reputable resources. ... 

Two recently published articles have helped to clarify this point a systematic review of randomized clinical trials on the upper gastrointestinal safety of celecoxib (90) and a population-based retrospective cohort comparison of the rate of upper gastrointestinal hemorrhages in over 40 000 NSAID-naive elderly users of non-selective NSAIDs, celecoxib, or rofecoxib with the rate in 100 000 patients who had not been exposed to NSAIDs (91). 

Therefore, it seems that the only dependable and safe cure for the hangover is time or, of course, drinking in moderation or not at all. The Pittler et al. (2005) article cited earlier confirmed this conclusion, as its review of clinical trials of interventions to treat hangover showed ncithing to be nearly as effective as preventing the symptoms from occurring in the first place. 

The first trial notification that is the first clinical trial in humans for the new substance, new administration route and new combination submitted to the Review Center should be reviewed under the new regulations. When there are no questions or instructions within 30 days, the sponsor can start the clinical trial. With other trial protocols, the sponsor has to submit to the Review Center although they do not have the review (Article 80-2-3 of the PAL. Notification No. 421, 1997). Modification of trial protocol, withdraw of trial and completion of trial are also submitted. 

Clinical Infectious Diseases—This journal, formerly named Reviews of Infectious Diseases, is an official publication of the IDSA. Articles are primarily directed at the diagnosis and treatment of infectious diseases, including clinical trials. Frequently, State of the Art articles are published that summarize current therapy of a particular infection. In addition, IDSA guidelines for the treatment of infectious diseases are published in this journal. 

Cancer Gene Therapy. 1994-. London, U.K/ Nature Publishing. Monthly. ISSN 0929-1903. URL http //www.nature.com/ cgt/. Presents results of laboratory investigations, preclinical studies, and clinical trials in the field of gene transfer/gene therapy as applied to cancer research, case reports, preliminary communications, review articles, and industry perspectives (descriptions of the newest technology being developed in the corporate sector). 

For a more detailed description of the concepts in critical appraisal, a series of articles published in the Journal of the American Medical Association (JAMA) provides a useful tool for practitioners who are evaluating clinical trials. ° These users guides to the medical literature—developed by The Evidence-Based Medicine Working Group, a group of clinicians at Canada s McMaster University and colleagues across North America—can help to assess the validity of primary studies as well as review articles. 

Price. Antimicrob. Ag. Chemother. 11, 324 (1977). Pharmacology M. Pfeifer el at, ibid. 331 A. I. Hart stein etaL. ibid. 12, 93(1977). Review J. Antimicrob. Chemother. 10, Suppl. B, 1-162 (1982). Series of articles on clinical trials in respiratory tract infections Drugs 32, Suppl. 3, 1-56 (1986). 

Clinical trial in chronic cerebrovascular disorders A- Ag-noli el a/.. IM, J. Clin. Pharm. Res. 8, 189 (1988). Series of articles on absorption, distribution, excretion and metabolism ArzneimitteFForsch. 33, 1135-1151 (1983). Review of pharmacology, toxicology and clinical studies B. Holmes el al. Drugs 27, 6 (1984). 

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