Download Appropriate Dose Selection — How to Optimize Clinical Drug by T. Singer (auth.), J. Venitz, W. Sittner (eds.) PDF

By T. Singer (auth.), J. Venitz, W. Sittner (eds.)

Optimal dose individualization has turn into extra vital in bettering scientific efficacy and protection, given the range in drug reaction, e.g., because of concurrent health problems or co-medications. for this reason, the position of optimum dose discovering in early scientific drug improvement to be able to maximize winning medical use is emphasised. the continuing use of biomarkers – according to the (known) pharmacology of the drug and/or biology of the underlying affliction – besides exposure–response overview all through all levels of drug improvement can quantitatively combine medical pharmacology wisdom, offer early evidence of notion, and assist in rational dose choice and rational drug product labeling for scientific use.

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1997, 2003). Biomarkers are perhaps most useful in early phase of clinical development, when measurement of clinical endpoints may be too timeconsuming or cumbersome to provide timely proof of concept (POC) or dose-ranging information. The use of changes in biochemical or clinical biomarkers in early clinical drug development to establish POC is only as good as the theoretical foundation for the biochemical or clinical biomarker. The scientific program for evaluating biomarkers must be planned as early as possible in the drug discovery and preclinical period of drug development with the aim to bring that biomarker into clinical 38 J.

3 Why Do We Need Biomarkers? . . . . . . . . 4 Validation . . . . . . . . . . . . . . 5 Regulatory Aspects . . . . . . . . . . . . 1 Cardiovascular . . . . . . . . . . . . . 2 Pulmonology . . . . . . . . . . . . . . 3 CNS System . . . . . . . . . . . . . . 7 Conclusions . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 31 32 34 35 37 38 39 41 42 42 Abstract.

The vast majority of nonlinear PK situations have been observed at the upper end of the dose range of drugs in association with saturation of ratelimiting processes such as dissolution of solid drug forms or metabolism by specific enzymes with limited capacity, either presystemically during the absorption phase or during the elimination phase. These types of nonlinearity are frequently observed at high doses used in nonclinical toxicology studies but have also been observed within the therapeutic range of certain drugs in humans.

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