Databases preclinical development

To simplify the process, it is important that a single database is developed for the whole programme. This is particularly relevant to the production of safety data, not only in the interests of efficiency but also so that any safety issues will be recognised as they arise. If a particular set of adverse events is suggested by preclinical toxicology then they should be flagged in the database so that the monitors attention is drawn to them. 

This strategy is highly successful for impurity identification (Kerns et al., 1995) during preclinical development. When information is stored within a comparative database, this approach is also highly effective for protein identification (Arnott et al., 1995). In these applications, the characteristic fragmentation corresponding to amino acid residues provides the searchable template for identification. This approach is particularly useful when identification studies are required for vast numbers of compounds or for samples that contain many analytes of interest. 

These identified AE-drug combinations are hypotheses for further testing follow-up may be necessary to determine whether they represent a potential drug safety issue. Further evaluation may include a query and review of the company s safety database, review of the scientific literature and preclinical data and consultation/discussion with internal and external experts. If a product safety issue was identified, next steps would include the development of a risk management and risk communication plan. 

IMS R D Focus. IMS Health, 660 West Germantown Pike, Plymouth Meeting, PA 19462-0905, U.S.A. Phone +1 610-834-5000. URL http //www.ims-global.com. IMS s pipeline database, R D Focus, covers approximately 8500 drugs in development from preclinical through launch. The database is part of the IMS Lifecycle collection of databases. This collection includes New Product Focus, which covers launched drugs and Patent Focus, which covers the patent status of compounds. The product is available via an Internet subscription, CD-ROM or online. Customized licenses are available upon request. 

FIGURE 25.2 (a) Increase in MW over time of published medici-nai compounds, (b) Mean MW through clinical development (Source Investigational Drugs Database). Similar results found by Blake and Wenlock et al . The increase in MW between discovery compounds (leads) and preclinical compounds (candidates) has been studied in detaii by Oprea et... 

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