Drug Development Clinical Testing

DiMasi, J.A., Success rates for new drugs entering clinical testing in the United States, Clin. Pharmacol. Therap., 58,1-14,1995 DiMasi, J.A., Trends in drug development costs, times and risks. Drug Inform. /., 29, 375-384,1995. 

The chief concern about government attempts to develop drugs through clinical testing levels is that the government s decisions as to which products... 

Poor pharmacokinetics and toxicity are important causes of costly late-stage failures in drug development. It is generally recognized that, in addition to optimized potency and specificity, chemical libraries should also possess favorable ADME/Tox and druglike properties [77-80]. Assessment of druglike character is an attempt to decipher molecular features that are likely to lead to a successful in vivo and, ultimately, clinical candidate [81-83]. Many of these properties can be predicted before molecules are synthesized, purchased, or even tested in order to improve overall lead and library quality. 

R D Focus. This database service [66] provides information on over 7000 drugs in active development. The service monitors the development, efficacy, and status of pharmaceuticals from early clinical testing through to launch. Data are gathered through direct contact with manufacturers and research organizations. It appraises both the scientific and commercial aspects of drug development and is searchable by product, by phase, by mechanism of action, and by country. R D Focus product is commercially available in several formats. 

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