Clinical Pharmacology Drug Database

Ito, K., Brown, H.S. and Houston, J.B. (2004) Database analyses for the prediction of in vivo drug-drug interactions from in vitro data. British Journal of Clinical Pharmacology, 57 (4), 473—486. 

As many new drugs are subjected to a TQT study, the FDA will receive more and more information from sponsors. In order to capture all the data in submissions in a single location for future reference, and for future data analysis, a database with an analytical tool—the Qtech— was developed in the Office of Clinical Pharmacology and Biopharmaceuticals within the FDA (15). The QTech is a Visual Basic... 

Drugs FDA. URL http //www.accessdata.fda.gov/scripts/ cder/drugsatfda/. [25 October 2005]. This is a searchable database of NDAs and AND As submitted to the FDA s Center for Drug Evaluation and Research. The approval history and labeling are generally provided for each product. Links to the complete review, including the clinical pharmacology section, are sometimes available. 

CSline. CSline [84] provides information on well-designed and well-executed clinical trials of drugs currently under study or in use in humans. This information includes study objectives, design, population, intervention groups, withdrawals, adverse reactions, endpoints and results, conclusions, and references. The CSline database covers more than 500 drugs currently on the market or in development. Pharmacological data from more than 2000 journal articles, congresses, and books are added each year. The product is commercially available on CD-ROM from Prous Science and is updated every 2 months. 

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