The Role of Pharmacological Predictors in Dru Development在药物开发中的药物的预测作用.pptVIP

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The Role of Pharmacological Predictors in Dru Development在药物开发中的药物的预测作用.ppt

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The Role of Pharmacological Predictors in Dru Development在药物开发中的药物的预测作用

Resistance Development Approved Antibacterial Agents1983-2004 Pharmacokinetics Problems: Protein Binding Tissue Distribution Blister Fluid Clinical study Cefpodoxime and Cefixime To compare the soft tissue distribution of these two antibiotics after 400mg oral dose in healthy male volunteers by microdialysis Two way cross-over, single oral dose study Microdialysis Pharmacokinetics Pharmacodynamics Problems: MIC is imprecise MIC is monodimensional MIC is used as a threshold When MIC does not explain the data, patches are used(post-antibiotic effect, sub-MIC effect) Kill Curves Kill Curves of Ceftriaxone Kill Curves of Ceftriaxone Plasma and free tissue levels Plasma and free tissue levels Resistance Modeling Pre-existing subpopulations Emerging subpopulations Adaptive resistance (transporters) Proposal Wild Card Patent Extension ISAPInternational Society of Anti-Infective Pharmacology Workshops at ECCMID and ICAAC Symposia at ECCMID and ICAAC Joint Symposium with FDAand IDSA Website with slides, presentations and tons of information Maximum Growth Rate Constant k Maximum Killing Rate Constant k-kmax PK-PD Model Initially, bacteria are in log growth phase Single Dose Piperacillin vs. E. coli Dosing Interval Piperacillin (2g and 4g) vs. E. coli q24h q8h q4h PK-PD Model In animals Bacterial survival fraction of P. aeruginosa in a neutropenic mouse model at different doses (mg/kg) of piperacillin (Zhi et al., 1988) FDA Draft-Guidance for Industry (1997) Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products New Dosage Form of a Previously Studied Drug In some cases, modified release dosage forms may be approved on the basis of pharmacokinetic data linking the new dosage form from a previously studied immediate-release dosage form. Because the pharmacokinetic patterns of controlled-release and immediate release dosage forms are not identical, it is generally important to have some understanding of the relationship of blood conc