Appropriate Dose Selection — How to Optimize Clinical Drug - download pdf or read online

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

ISBN-10: 3540278672

ISBN-13: 9783540278672

ISBN-10: 3540495290

ISBN-13: 9783540495291

Optimal dose individualization has develop into extra very important in enhancing medical efficacy and safeguard, 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 to be able to maximize winning medical use is emphasised. the ongoing use of biomarkers – in accordance with the (known) pharmacology of the drug and/or biology of the underlying disorder – in addition to exposure–response review all through all levels of drug improvement can quantitatively combine medical pharmacology wisdom, supply early evidence of suggestion, and assist in rational dose choice and rational drug product labeling for scientific use.

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1997). The mechanism of action and the blood pressure-lowering effect could later be confirmed in clinical trials with patients suffering from mild to moderate hypertension (Wensing et al. 2005). Sufficient decision-making information for the continued development of the compound was obtained from these early clinical–pharmacological studies in healthy volunteers and patients. 2 Pulmonology Leukotriene Receptor Antagonist Bronchial challenges are an ideal tool to assess the pharmacodynamic effect and duration of new antiasthmatic drugs early in the course of drug development and provide a rationale for the selection of doses and dosing schedules in clinical trials.

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.

JAMA 285:2486–2497 CMR International (2004) The CMR International R&D Factbook, Centre for Medicines Research International Ltd Colburn WA (2000) Optimizing the use of biomarkers, surrogate endpoints, and clinical endpoints for more efficient drug development. J Clin Pharmacol 40:1419–1427 Danhof M, Alvan G, Dahl SG et al (2005) Mechanism-based pharmacokinetic – pharmacodynamic modelling – a new classification of biomarkers. Pharm Res 22:1432–1437 Food and Drug Administration Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research (1998) Guidance for industry: providing clinical evidence of effectiveness for human drug and biological products.

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

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