Pharmacokinetics/Pharmacodynamics Model-Supported Early Drug Development
| Autor: | Bin Chen, Wei-Jian Pan, Jennifer Q. Dong, Ana Lúcia Tasca Gois Ruiz |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Drug
Oncology medicine.medical_specialty Physiologically based pharmacokinetic modelling media_common.quotation_subject Pharmaceutical Science Pharmacology Models Biological Pharmacokinetics Internal medicine Drug Discovery Animals Humans Medicine Computer Simulation media_common Dose-Response Relationship Drug business.industry Late stage Pharmaceutical Preparations Drug development Pharmacodynamics Meta-analysis business Early phase Biotechnology |
| Zdroj: | Current Pharmaceutical Biotechnology. 13:1360-1375 |
| ISSN: | 1389-2010 |
| DOI: | 10.2174/138920112800624436 |
| Popis: | Pharmacokinetic/pharmacodynamic (PK/PD) modeling & simulation (M&S) provides quantitative assessment of dose/exposure-response relationships with extensive applications at the late stage drug development as well as during regulatory decision making. However, at preclinical and early phase clinical drug development, the importance of PK/PD M&S has not been as widely recognized. We reviewed selected PK/PD M&S literatures in order to convey importance of M&S in these early development phases. We focused on the application of M&S to select and optimize lead candidates, the use of preclinical PK/PD data to project the range of clinical doses, and the development of comprehensive dose/exposure-response models that can be used to forecast the probability of achieving a target response based on Phase 1 safety, PK and biomarker information. We also reviewed several other M&S approaches that are often used in early drug development such as physiologically-based pharmacokinetic (PBPK) modeling, meta-analysis, PK-pharmacogenomics modeling, and etc. Our aims were to provide expert opinions on the practical utility of PK/PD model-based approaches that have positive impact on early decision-making with the goal of improving the success rate of early to late stage drug development. |
| Databáze: | OpenAIRE |
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