By J. Venitz, W. Sittner
Optimum dose individualization has develop into extra vital in bettering medical efficacy and safeguard. this is often due partly to the range in drug reaction. as a result, the function of optimum dose discovering in early scientific drug improvement on the way to maximize winning medical use is emphasised. This ebook reports cutting edge equipment, instruments and examples of rational drug improvement techniques, relatively for novel oncological brokers.
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Extra resources for Appropriate Dose Selection - How to Optimize Clinical Drug Development (Ernst Schering Foundation Symposium Proceedings 59)
Kuhlmann Kuhlmann J (1999) Alternative strategies in drug development: clinical pharmacological aspects. Int J Clin Pharmacol Ther 37:575–583 Lesko LJ, Atkinson AJ (2001) Use of biomarkers and surrogate endpoint in drug development and regulatory decision making: criteria, validation, strategies. Annu Rev Pharmacol Toxicol 41:347–366 Lesko LJ, Rowland M, Peck CC et al (2000) Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.
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. 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.
42 J. 7 Conclusions A biomarker of drug effects should reﬂect a process on the critical path between the target identiﬁcation, the pharmacological action of the drug and its effect on a disease. There is an acute need for effective biomarkers in every phase of research and development, from discovery to preclinical studies up to clinical trials in the early and late stages of development. Identifying novel biomarkers during these stages is an integral activity necessary for developing and delivering more efﬁcacious, safer drugs to patient populations.