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A multivariate approach to estimating the withdrawal time in food animal species

Abstract Number:

2681 

Submission Type:

Contributed Abstract 

Contributed Abstract Type:

Poster 

Participants:

Farha Ferdous Sheela (1), Ronald Baynes (2), Jim Riviere (3), Jacqueline Hughes-Oliver (4), Majid Jaberi-Douraki (3)

Institutions:

(1) N/A, N/A, (2) Dr., N/A, (3) Professor, N/A, (4) North Carolina State University, N/A

Co-Author(s):

Ronald Baynes  
Dr.
Jim Riviere  
Professor
Jacqueline Hughes-Oliver  
North Carolina State University
Majid Jaberi-Douraki  
Professor

First Author:

Farha Ferdous Sheela  
N/A

Presenting Author:

Farha Ferdous Sheela  
N/A

Abstract Text:

In the US, the FDA uses linear regression and non-central t distribution to estimate the upper limit of the 95% CI for the 99% quantile (TLM) and define the time as withdrawal time (WDT) when this TLM falls at or below a safe concentration level (tolerance) following the administration of the approved drug in labeled or extra-label manner in food animal species. It involves only the concentrations at or above the limit of detections (LODs) and determines the WDT for each tissue separately. However, the tissues, namely, liver, kidney, muscle, and fat collected from an animal, may be correlated. Therefore, the multivariate linear regression model (MvLR) appropriately addresses this high inter-tissue correlation. In addition, involving only the concentrations above LOD, censored observations can also impact the correlations or covariance pattern among the tissues and result in biased and imprecise estimators. Therefore, we propose using ordinary least squares (OLS), generalized least squares (GLS) in MvLR, and expectation-conditional maximization (ECM) algorithm in censored MvLR along with multivariate t distribution to estimate will provide more precise and accurate estimates of WDT.

Keywords:

TLM|WDT|Multivariate t distribution|OLS|GLS|ECM

Sponsors:

Biopharmaceutical Section

Tracks:

Miscellaneous

Can this be considered for alternate subtype?

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I have read and understand that JSM participants must abide by the Participant Guidelines.

Yes

I understand that JSM participants must register and pay the appropriate registration fee by June 3, 2025. The registration fee is non-refundable.

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