Practical Aspects of Population Pharmacokinetics & Pharmacodynamics
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- Komatsu Kanji
- Astellas Pharma Inc.
Bibliographic Information
- Other Title
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- 母集団PKPD解析の実際
- ボシュウダン PKPD カイセキ ノ ジッサイ
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Abstract
The practical aspects of population pharmacokinetics / pharmacodynamics (PK/PD) are summarized. Recently, the progress and application of Model-Based Drug Development (MBDD) in pharmaceutical industries is remarkable and the acceptance of model-based results are getting wider in regulatories of US, EU and Japan. In MBDD, PKPD modeling based on nonlinear mixed effects model (NLMEM) plays an important role, and it provides the quantitative results which help the decision-making in projects. The understanding of its methodology is quite important for pharmacometricians and biostatisticians. In this article, objective, design and modeling methodology (scheme, diagnostics and validation) are briefly described. The research on methodology in NLMEM is still growing, and pharmacometricians should follow its rapid evolution.
Journal
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- Japanese Journal of Biometrics
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Japanese Journal of Biometrics 36 (Special_Issue), S49-S63, 2015
The Biometric Society of Japan
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Keywords
Details 詳細情報について
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- CRID
- 1390001204369765632
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- NII Article ID
- 130005097964
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- NII Book ID
- AA11591618
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- ISSN
- 21856494
- 09184430
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- NDL BIB ID
- 026672153
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- Text Lang
- ja
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- Data Source
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- JaLC
- NDL
- Crossref
- CiNii Articles
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- Abstract License Flag
- Disallowed