NDLI: Handling Missing Data in a Duloxetine Population Pharmacokinetic/Pharmacodynamic Model

Content Provider	Springer Nature Link
Author	Yuen, Eunice Gueorguieva, Ivelina Aarons, Leon
Copyright Year	2014
Abstract	In pharmacokinetic (PK)/pharmacodynamic (PD) modelling and simulations (M&S), omitting dropouts can cause inaccuracies in parameter estimation and clinical trial simulations (CTS). This study examines the impact of different imputation methods for missing data on the interpretation of model results, as well as develops a selection model (where dropout and efficacy are jointly modelled) for use in CTS.Missing data were imputed using single and multiple imputation and pattern mixtures methods for a previously reported duloxetine PK/PD model. The probability of dropout was described in the selection model and CTS was conducted with a hypothetical drug to examine the impact of dropout on trial results.The study completion rate was 75% and dropouts were not random. Model parameters obtained with different imputation methods were mostly within 40% (range 0 to 63%) compared to the model without dropouts. CTS showed 0.3 points lower median pain scores and 3% lower coefficient of variation over the 12-week simulations when dropout was included.Missing data had little impact on the original population PK/PD analyses. Sensitivity analyses for dropouts should be conducted in M&S exercises. The utility of selection models in CTS was explored via a hypothetical case study.
Starting Page	2829
Ending Page	2843
Page Count	15
File Format	PDF
ISSN	07248741
Journal	Pharmaceutical Research
Volume Number	31
Issue Number	10
e-ISSN	1573904X
Language	English
Publisher	Springer US
Publisher Date	2014-05-03
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Pharmacology/Toxicology Pharmacy Biochemistry Medical Law Biomedical Engineering
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Pharmacology Molecular Medicine Pharmacology (medical) Biotechnology Pharmaceutical Science

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Population Pharmacokinetic/Pharmacodynamic Model for the Sedative Effects of Flibanserin in Healthy Volunteers

Population Pharmacokinetic-Pharmacodynamic Model of Craving in an Enforced Smoking Cessation Population: Indirect Response and Probabilistic Modeling

Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for THIOMAB™ Drug Conjugates

Gene Therapy: A Pharmacokinetic/Pharmacodynamic Modelling Overview

A New Exact Test for the Evaluation of Population Pharmacokinetic and/or Pharmacodynamic Models Using Random Projections

Receptor-Mediated Pharmacokinetic/Pharmacodynamic Model of Interferon-β 1a in Humans

Pharmacokinetic and Pharmacodynamic Modeling of Romiplostim in Animals

Preclinical Pharmacokinetic/Pharmacodynamic Models to Predict Schedule-Dependent Interaction Between Erlotinib and Gemcitabine

Sex Specificity in Methadone Analgesia in the Rat: A Population Pharmacokinetic and Pharmacodynamic Approach

Handling Missing Data in a Duloxetine Population Pharmacokinetic/Pharmacodynamic Model – Imputation Methods and Selection Models

Similar Documents

Population Pharmacokinetic/Pharmacodynamic Model for the Sedative Effects of Flibanserin in Healthy Volunteers

Population Pharmacokinetic-Pharmacodynamic Model of Craving in an Enforced Smoking Cessation Population: Indirect Response and Probabilistic Modeling

Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for THIOMAB™ Drug Conjugates

Gene Therapy: A Pharmacokinetic/Pharmacodynamic Modelling Overview

A New Exact Test for the Evaluation of Population Pharmacokinetic and/or Pharmacodynamic Models Using Random Projections

Receptor-Mediated Pharmacokinetic/Pharmacodynamic Model of Interferon-β 1a in Humans

Pharmacokinetic and Pharmacodynamic Modeling of Romiplostim in Animals

Preclinical Pharmacokinetic/Pharmacodynamic Models to Predict Schedule-Dependent Interaction Between Erlotinib and Gemcitabine

Sex Specificity in Methadone Analgesia in the Rat: A Population Pharmacokinetic and Pharmacodynamic Approach

Handling Missing Data in a Duloxetine Population Pharmacokinetic/Pharmacodynamic Model – Imputation Methods and Selection Models