Drug development 740 INDEX

Sources. (1) PhRMA (Pharmaceutical Research and Manufacturers of America) Press Release dated November 14, 2006. http //www.who.int/mediacentre/factsheets/fs310/en/ index.html [accessed April 19, 2007], (2) CNN.com. Largest Passenger Jet Unveiled, January 18,2005. http //www.cnn.eom/2005/BUSINESS/01/18/airbus.380/ [accessed April 19, 2007], (3) Tufts Center for the Study of Drug Development, http //www.bizjournals.com/ sanfrancisco/stories/2006/12/04/newscolumn3.html [accessed September 26,2007]. 

Center for Drug Evaluation and Research. New Drug Development and Review Process, FDA, Rockville, MD. http //www.fda.gov/cder/handbook/index.htm [accessed July 2, 2007]. 

In addition, the International Conference on Harmonization has issued a guidance document pertinent to pediatric drug development Ell, Clinical Investigation of Medicinal Products in the Pediatric Population (www.fda.gov/cder/guidance/index.htm). 

At later stages of drug development (before Phase I), when the test substance has been more fully characterized, the Irwin Test provides a clear over-all index of the test substance s margin of safety. Furthermore, although the test is mainly behavioral, it can give global indications of drug effects on vital functions such as respiration or intestinal motility. On the other hand, the test provides little information about effects... 

A regulatory professional must be aware of the guidance documents that FDA has made available to assist industry to understand expectations regarding drug development and the approval process. The website providing the complete list of FDA guidances is updated almost daily. It may be accessed at http //www. fda.gov/cder/guidance/index.htm. 

The failure of drugs at later stages of development, particularly in clinical trials, is very expensive for drug developers and, more importantly, patients. To better understand the key reasons for these failures, Lipinski et al,14 undertook an analysis of the properties of compounds that entered Phase II human clinical trials. They selected a subset of 2245 compounds from the World Drug Index (WDI) database of over 50000 compounds after eliminating the majority of compounds for various well-reasoned criteria. This subset of compounds had assigned trade names and, as a result, were assumed to have entered Phase II oral efficacy studies and be expected to have superior physico-chemical properties since they would have passed most of the other earlier clinical trial hurdles. 

CDER. Guidance for Industry. Drug interac-tion/drug metabolism studies in the drug development process Studies in vitro. Rockville, MD Eood and Drug Administration 1997. (Internet at http //www.fda.gov/cder/guidance/index.htm.)... 

CAplus is particularly useful to do research for the first stages of drug development. However, it is not so useful for clinical practice. Inevitably, the best way to search for a substance is to use its CAS registry number. It is even possible to draw a chemical structure and conduct a search on it for post-1966 data. Generic and brand names are indexed for searching only if they are provided by the author in the original source. 

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