Drug discovery today
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Drug discovery today · Aug 2004
Biography Historical ArticleArnold O. Beckman, inventor and philanthropist.
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Drug discovery today · Jul 2004
Janet Woodcock discusses the FDA and the drug development process. Interview by Christopher Watson.
Currently Acting Deputy Commissioner for Operations at FDA, Janet Woodcock has served as Director, Center for Drug Evaluation and Research at FDA since 1994. She previously served in other positions in FDA including Director, Office of Therapeutics Research and Review and Acting Deputy Director, Center for Biologics Evaluation and Research. She received her MD from Northwestern Medical School and held faculty appointments at the Pennsylvania State University and the University of California in San Francisco. She joined FDA in 1986.
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Drug discovery today · May 2004
ReviewStrategies to identify ion channel modulators: current and novel approaches to target neuropathic pain.
Modulation of ion channel function has been a successful area for drug development, with ion channel modulating drugs being used in the therapeutic treatment of epilepsy, hypertension, diabetes and chronic pain. Most of the ion channel-modulating drugs that are currently on the market were developed without extensive knowledge of the molecular structure of ion channels, or an understanding of the full complexity of ion channel subtypes or knowledge of how ion channel expression is regulated during pathology. As new information on the roles that different ion channel subtypes play in pathophysiological processes becomes available, drugs will be designed to target specific ion channel subtypes via mechanisms that involve either direct channel block or modulation of ion channel functional expression. Using neuropathic pain as an example, this article reviews current knowledge of the structure and function of ion channels and current technology and future opportunities for the identification of novel drugs that are capable of modulating ion channel function.
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Drug discovery today · Apr 2004
ReviewThe advantages and disadvantages of adaptive designs for clinical trials.
Flexible designs for clinical trials permit mid-trial design modifications, which are based on interim information from inside or outside the trial while meeting (regulatory) requirements for the control of the type I error rate. The basic principle is to combine stage standardized test statistics such as p-values or z-scores in a pre-specified way. The flexibility covers changes of sample sizes, treatment allocation ratios and the number of interim analyses, as well as the selection of treatments, doses and end points. The price to be paid is that non-standard test statistics must be used after an adaptation.