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Activity Number:
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24
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Type:
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Contributed
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Date/Time:
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Sunday, August 6, 2006 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305624 |
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Title:
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Assessing PK-AE Relationships Using Nonlinear Models
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Author(s):
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Haiyuan Zhu*+
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Companies:
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Merck Research Laboratories
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Address:
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126 E. Lincoln Ave., Rahway, NJ, 07065,
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Keywords:
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PK/PD modeling ; adverse events ; odds ratio ; plateau
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Abstract:
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Adverse events (AEs) occur in preclinical and clinical trials. Understanding the relationship between a drug's Pharmacokinetic (PK) profile and AEs is crucial to finding the maximum tolerated dose and clinical dose in drug development. One question often asked during dose finding is whether a plateau in the incidence of AEs has been reached at a dose or plasma concentration level. However, commonly used logistic regression models are not capable of addressing this question. For this reason, nonlinear models are proposed to model the PK/AE relationships. Log odds ratio, which is a function of plasma concentration in these nonlinear models, is studied and a testing procedure for plateau hypothesis is constructed based on simultaneous confidence band for the log odds ratio curve. An example is used to illustrate the model fitting and testing procedure.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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