Abstract
In an ideal world, a pharmaceutical drug would be highly effective without side effects in patients correctly predicted to be susceptible to the beneficial effects of the respective drug. The drug manufacturer would be able to identify a disease entity worth investing in, because reimbursement would be assured. On the basis of genomic knowledge, molecular diseases and treatment targets would be readily identifiable, and their validation would pose no problem in terms of investment and time due to the availability of appropriate technology. Biomarkers (already validated) should guide an accelerated clinical development process to regulatory approval ensuring no unpleasant surprises concerning safety in the post-approval period.
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Burger, K. (2011). Pharmacogenomic-Guided Drug Development. In: Vogel, H.G., Maas, J., Gebauer, A. (eds) Drug Discovery and Evaluation: Methods in Clinical Pharmacology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-89891-7_39
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DOI: https://doi.org/10.1007/978-3-540-89891-7_39
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