| Clinical development of atypical antipsychotics: research design and evaluation. Collaborative Working Group on Clinical Trial Evaluations. | |
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MedLine Citation:
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PMID: 9766614 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Clinical trials support the efficacy and safety of new drugs on the market. They provide the United States Food and Drug Administration with the information needed to approve an Investigational New Drug application and are the basis for package inserts provided by the manufacturers that guide clinicians in the use of a new drug. Because clinical trials are vital to the effective and safe use of new drugs, it is important to understand who participates in them, what questions are answered by clinical trials, and what questions are raised. The reader who asks the proper questions about issues such as methodology, affiliations of the investigators, statistical analyses performed, location of study centers, and study populations will derive the most information from the report of a clinical trial. |
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Authors:
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Publication Detail:
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Type: Journal Article; Multicenter Study; Review |
Journal Detail:
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Title: The Journal of clinical psychiatry Volume: 59 Suppl 12 ISSN: 0160-6689 ISO Abbreviation: J Clin Psychiatry Publication Date: 1998 |
Date Detail:
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Created Date: 1998-10-20 Completed Date: 1998-10-20 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 7801243 Medline TA: J Clin Psychiatry Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 10-6 Citation Subset: IM |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Antipsychotic Agents / adverse effects, economics, therapeutic use* Clinical Trials as Topic / methods*, standards*, statistics & numerical data Cross-Cultural Comparison Drug Administration Schedule Drug Approval / legislation & jurisprudence Drugs, Investigational / adverse effects, economics, therapeutic use Europe Female Humans Male Placebos Psychiatric Status Rating Scales Research Design / standards, statistics & numerical data Schizophrenia / drug therapy United States United States Food and Drug Administration |
| Chemical | |
Reg. No./Substance:
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0/Antipsychotic Agents; 0/Drugs, Investigational; 0/Placebos |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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