Download Appropriate Dose Selection - How to Optimize Clinical Drug by J. Venitz, W. Sittner PDF

By J. Venitz, W. Sittner

Optimum dose individualization has turn into extra very important in enhancing medical efficacy and protection. this is often due partially to the variety in drug reaction. for this reason, the function of optimum dose discovering in early medical drug improvement so one can maximize winning scientific use is emphasised. This publication studies leading edge equipment, instruments and examples of rational drug improvement concepts, relatively for novel oncological brokers.

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Additional info for Appropriate Dose Selection - How to Optimize Clinical Drug Development (Ernst Schering Foundation Symposium Proceedings 59)

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Br J Clin Pharmacol 42:171– 178 Wensing G et al (2005) Early PoM/PoP in healthy volunteers or patients? Example of an angiotensin-II antagonist (abstract). 7th Congress of European Association for clinical Pharmacology and Therapeutics. Basic Clin Pharmacol Toxicol 97 [Suppl I]:26 Workshop on Bioanalytical Methods Validation for Macro-molecules: Summary Report 2001. Pharm Res 18:1373–1383 4 Using Exposure – Response and Biomarkers to Streamline Early Drug Development J. 2 Guiding Principles . .

49 49 50 51 53 53 56 58 58 58 61 62 Abstract. Biomarkers (BMs) are biological measures of PD drug effects or disease markers that may represent clinically significant patient outcomes, either efficacy or toxicity. Their use in drug development, especially as an integral part of PK/PD modeling, has become a popular strategy for optimizing development time and resources. This approach supports quantitative integration of information across different species and throughout the clinical phases I–III.

To reduce speculation, retrospective and more recently prospective analyses have been carried out. To explore the utility of microdosing at Pfizer, a retrospective analysis of in-house phase I data has been done (Smith et al. 2003). The PK profile of 12 (recently evaluated) compounds at a low dose (usually < 5 mg) was compared to that at pharmacologically active doses. In six cases, more or less linear PK was observed and therefore microdosing would have probably been predictive. However, it was noted that of these six, two would have had predictable human PK from preclinical data and the other four were active at low doses – which would have posed (nonradiolabeled) analytical problems at a safe microdose level.

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