Drug development safety pharmacology

Safety pharmacology satisfies a key requirement in the process of drug development. Safety pharmacology studies are required to assess the impact of a new... 

NPs and other safety biomarkers can be applied even earlier in drug development while pharmacology is still being assessed (Engle et al., 2009). Thanks to cross-species sequence homology and conservation of function, NTproANP can be measured in mice using the same assay used for rat samples. NTproANP concentrations measured in mouse... 

Whitebread, S., Hamon, J., Bojanic, D., and Urban, L. (2005). In vitro safety pharmacology profiling An essential tool for successful drug development. Drug Disc. Today 10 1421-1433. 

The emphasis at this stage of the drug development process is upon assessing safety. Satisfactory pharmacological, and particularly toxicological, results must be obtained before any regulatory authority will permit commencement of human trials... 

The initiative to add mandated safety pharmacology studies to the drug development process is overdue in arriving. However, its actual implementation and the use of the resulting data in risk/benefit decision will take some time to be worked out. During the year 2001, many small companies were put in a difficult position when the... 

Fujimori, K. (1999). The role of general pharmacological studies and pharmacokinetics in the evolution of drugs (1) The role of general/safety pharmacology studies in the development of pharmaceuticals International harmonization guidelines. Folia Pharmacologica Japo-... 

Martin, L.I., Horvath, C.J. and Wyand, M.S. (1997). Safety pharmacology screening practical problems in drug development. Int. J. Toxicol. 16 41-65. 

There is a considerable interest in computational models to predict the safety of NCEs in the drug discovery and development phases. Insight into the safety pharmacological potential of a scaffold or series of structures early in the drug discovery process could help the medicinal chemists to prioritize particular scaffolds or hits or alternatively can contribute halting the discovery process for a given research project. The main safety... 

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