By T. Singer (auth.), J. Venitz, W. Sittner (eds.)
Optimal dose individualization has turn into extra very important in enhancing scientific efficacy and defense, given the variety in drug reaction, e.g., as a result of concurrent health problems or co-medications. for this reason, the position of optimum dose discovering in early scientific drug improvement on the way to maximize winning scientific use is emphasised. the ongoing use of biomarkers – in accordance with the (known) pharmacology of the drug and/or biology of the underlying illness – in addition to exposure–response overview all through all levels of drug improvement can quantitatively combine medical pharmacology wisdom, offer early evidence of proposal, and assist in rational dose choice and rational drug product labeling for scientific use.
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Extra info for Appropriate Dose Selection — How to Optimize Clinical Drug Development
2-fold. For both doses, only three out of six volunteers showed a protective effect against LTD4 -induced bronchoconstriction 8 h after drug administration (Wensing et al. 1996). For the different doses tested, a clear dose–response relationship was observed. Although the relevance of challenge studies with LTD4 for the prediction of efﬁcacy in bronchial asthma remains to be established, the outcome of bronchoprovocation testing in early studies in healthy volunteers is usually taken as a go/no go decision of a further drug development.
3 CNS System . . . . . . . . . . . . . . 7 Conclusions . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 31 32 34 35 37 38 39 41 42 42 Abstract. Selecting and evaluating biomarkers in drug discovery and early drug development can substantially shorten clinical development time or the time to reach a critical decision point in exploratory drug development. Critical decisions such as candidate selection, early proof of concept/principle, dose ranging, development risks, and patient stratiﬁcation are based on the appropriate measurements of biomarkers that are biologically and/or clinically validated.
More knowledge about pathophysiology of the disease and the drug has been obtained. Advantages of using biomarkers in drug discovery and preclinical development including toxicology are summarized in Table 4. Increasing use of biomarkers in early clinical development helps to streamline development by relating clinical data to preclinical test systems, determining whether the drug is reaching and affecting its molecular target in a human patient, and modeling phase I and phase II/III clinical trials.
Appropriate Dose Selection — How to Optimize Clinical Drug Development by T. Singer (auth.), J. Venitz, W. Sittner (eds.)