Analytical Methodology and the Interface with Animal Drug Approval
نویسندگان
چکیده
منابع مشابه
Drug approval and drug effectiveness.
Data on the efficacy and safety of psychiatric medicines should form the foundation of evidence-based treatment practices. The US Food and Drug Administration (FDA) reviews such data in determining whether to approve new treatments, and the published literature serves as a repository for evidence on treatment benefits and harms. We describe the FDA review of clinical trials, examining the under...
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چکیده ندارد.
FDA drug approval summaries: oxaliplatin.
The purpose of this report is to summarize information on oxaliplatin, a drug recently approved by the U.S. Food and Drug Administration. Information provided includes regulatory history, study design, efficacy and safety results, and pertinent literature references. A single, multicenter, randomized trial, enrolling 463 patients with metastatic colorectal carcinoma whose disease had recurred o...
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Patients with hormone-sensitive breast cancer who have responded to tamoxifen may receive additional benefit from a second endocrine agent following progression or relapse after tamoxifen therapy. Fulvestrant (Faslodex((R)), ICI 182780, AstraZeneca Pharmaceuticals; Wilmington, Delaware) is a selective antagonist of estrogen designed to have no estrogenic effects. Lack of aqueous solubility led ...
متن کاملthe evaluation of language related engagment and task related engagment with the purpose of investigating the effect of metatalk and task typology
abstract while task-based instruction is considered as the most effective way to learn a language in the related literature, it is oversimplified on various grounds. different variables may affect how students are engaged with not only the language but also with the task itself. the present study was conducted to investigate language and task related engagement on the basis of the task typolog...
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ژورنال
عنوان ژورنال: Journal of AOAC INTERNATIONAL
سال: 1978
ISSN: 0004-5756
DOI: 10.1093/jaoac/61.5.1183