| Pharmacokinetics/Pharmacodynamics Model-Supported Early Drug Development. | |
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MedLine Citation:
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PMID: 22201585 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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Bin Chen; Jennifer Q Dong; Wei-Jian Pan; Ana Ruiz |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-9-1 |
Journal Detail:
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Title: Current pharmaceutical biotechnology Volume: - ISSN: 1873-4316 ISO Abbreviation: - Publication Date: 2012 Sep |
Date Detail:
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Created Date: 2011-12-28 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100960530 Medline TA: Curr Pharm Biotechnol Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Global Clinical Pharmacology, Johnson & Johnson Pharmaceutical Research & Development 3210 Merryfield Row, San Diego, CA 92121. Bchen41@its.jnj.com. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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