By T. Singer (auth.), J. Venitz, W. Sittner (eds.)
Optimal dose individualization has turn into extra very important in enhancing medical efficacy and defense, given the variety in drug reaction, e.g., because of concurrent health problems or co-medications. consequently, the position of optimum dose discovering in early scientific drug improvement with a purpose to maximize winning medical use is emphasised. the continuing use of biomarkers – in response to the (known) pharmacology of the drug and/or biology of the underlying sickness – besides exposure–response review all through all stages of drug improvement can quantitatively combine scientific pharmacology wisdom, supply early evidence of thought, and assist in rational dose choice and rational drug product labeling for medical use.
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Extra resources for Appropriate Dose Selection — How to Optimize Clinical Drug Development
Expensive late-stage development failures could be shifted to less expensive early drug development go/no go decision making. References Abram TS, Cuthbert NJ, Francis HP et al (1987) Pharmacological proﬁle of BAY x 7195, a structural antagonist of cysteinyl-leukotrienes. Am Rev Respir Dis 147 [Suppl]:A179 Adelroth E, Sterk P, Adelroth EC et al (1986) Airway responsiveness to leukotrienes C4 and D4 and to methacholine in patients with asthma and normal controls. N Engl J Med 315:480–484 Arm J, Spur W, Lee TH (1988) The effects of inhaled leukotriene E4 in subjects with asthma and normal subjects.
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.
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.
Appropriate Dose Selection — How to Optimize Clinical Drug Development by T. Singer (auth.), J. Venitz, W. Sittner (eds.)