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研究性药物追踪:I至III期及新药申请提交——第一部分

Investigational drug tracking: Phases I-III and NDA submissions--Part I.

作者信息

Grant K L

机构信息

Drug and Poison Information Center, University of Wisconsin Hospital and Clinics, Madison.

出版信息

Hosp Pharm. 1994 Sep;29(9):830-6, 839-44, 847-52 passim.

PMID:10137064
Abstract

The author catalogs over 800 investigational drugs/biologicals currently in Phase I, II or III clinical trials or drugs/biologicals submitted to the FDA as new drug applications. The list assists in predicting when new drugs will be marketed. The entries include generic/chemical name, investigational drug number, synonyms, trade names, manufacturers, clinical trial status, predicted approval year, indications or drug class, whether the drug has been developed through biotechnology, and references. Entries were gleaned from medical journals, stock market analysis publications, and the Pharmaceutical Manufacturers Association's Medicines in Development Series. The list is alphabetized by the generic/chemical name or investigational drug number and cross-indexed by the trade name and synonyms. The list reflects those drugs which were not FDA approved as of April 15, 1994. Part I includes the trade name and synonym cross-indexes and the beginning of the main alphabetical listing by generic/chemical name or investigational drug number.

摘要

作者对目前处于Ⅰ期、Ⅱ期或Ⅲ期临床试验的800多种研究性药物/生物制品,或已作为新药申请提交给美国食品药品监督管理局(FDA)的药物/生物制品进行了编目。该列表有助于预测新药何时上市。条目包括通用名/化学名、研究性药物编号、同义词、商品名、制造商、临床试验状态、预计批准年份、适应症或药物类别、该药物是否通过生物技术研发以及参考文献。条目摘自医学期刊、股票市场分析出版物以及制药商协会的《研发中的药物系列》。该列表按通用名/化学名或研究性药物编号的字母顺序排列,并通过商品名和同义词进行交叉索引。该列表反映了截至1994年4月15日尚未获得FDA批准的那些药物。第一部分包括商品名和同义词交叉索引,以及按通用名/化学名或研究性药物编号排列的主要字母顺序列表的开头。

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