Drug development, process

The partition coefficient and aqueous solubility are properties important for the study of the adsorption, distribution, metabolism, excretion, and toxicity (ADME-Tox) of drugs. The prediction of the ADME-Tox properties of drug candidates has recently attracted much interest because these properties account for the failure of about 60 % of all drug candidates in the clinical phases. The prediction of these properties in an early phase of the drug development process could therefore lead to significant savings in research and development costs. 

The metabolism ofa potential drug has to be considered at an early phase of the drug development process. 

Walgren JL, Thompson DC. Application of proteomic technologies in the drug development process. Toxicol Lett 2004 149 377-85. 

The tools for in silico toxicology are broadly applied in the drug development process. The particular use of the tools is clearly context-dependent, which includes the quality of the prediction and the applicability domain of the model. 

DiMasi JA. The value of improving the productivity of the drug development process faster times and better decisions. In The cost and value of new medicines in an era of change. Pharmacoeconomics 2002 20(Suppl 3) 1-10. 

The New Drug Development Process Steps from Test Tube to New Drug Application Review, [Internet]. URL http //www.fda.gov/cder/handbook/ develop, htm, accessed 7-29-2000. 

Managing the Clinical Drug Development Process, David M. Coc-chetto and Ronald V. Nardi... 

The Drug Development Process Increasing Efficiency and Cost Effectiveness, edited by Peter G. Welling, Louis Lasagna, and Umesh V. Banakar... 

Physiologically based pharmacokinetic models provide a format to analyze relationships between model parameters and physicochemical properties for a series of drug analogues. Quantitative structure-pharmacokinetic relationships based on PB-PK model parameters have been pursued [12,13] and may ultimately prove useful in the drug development process. In this venue, such relationships, through predictions of tissue distribution, could expedite drug design and discovery. 

Braxton S et al. The integration of microarray information in the drug development process. Curr Opin Biotechnol 1998 9 643-649. 

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