Mechanism‐Based Pharmacokinetic–Pharmacodynamic Modeling During Discovery and Early Development

This chapter contains sections titled: Introduction Challenges in Drug Discovery and Development Methodological Aspects and Concepts Use of PK–PD Models in Lead Optimization Use of PK–PD Models in Clinical Candidate Selection Entry‐into‐Human Preparation and Translational PK–PD Modeling Use of PK–PD...

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Bibliographic Details
Published inSystems Biology in Drug Discovery and Development pp. 175 - 199
Main Authors Grimm, Hans Peter, Ou, Ying, Reddy, Micaela, David‐Pierson, Pascale, Lavé, Thierry
Format Book Chapter
LanguageEnglish
Published Hoboken, NJ, USA John Wiley & Sons, Inc 30.09.2011
Subjects
disease, pharmacodynamic response
PK–PD modeling, drug development
PK–PD, clinical candidate selection
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ISBN9780470261231
0470261234
DOI10.1002/9781118016435.ch8

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Summary:This chapter contains sections titled: Introduction Challenges in Drug Discovery and Development Methodological Aspects and Concepts Use of PK–PD Models in Lead Optimization Use of PK–PD Models in Clinical Candidate Selection Entry‐into‐Human Preparation and Translational PK–PD Modeling Use of PK–PD Models in Toxicology Study Design and Evaluation Justification of Starting Dose, Calculation of Safety Margins, and Support of Phase I Design Phase I and Beyond Support of Early Formulation Development Outlook and Conclusions References
ISBN:9780470261231
0470261234
DOI:10.1002/9781118016435.ch8