Approaches to handling missing or “problematic” pharmacology data: Pharmacokinetics

Author:

Irby Donald J.1,Ibrahim Mustafa E.2,Dauki Anees M.1,Badawi Mohamed A.1,Illamola Sílvia M.3,Chen Mingqing1,Wang Yuhuan4,Liu Xiaoxi4,Phelps Mitch A.1,Mould Diane R.15

Affiliation:

1. Division of Pharmaceutics and Pharmacology College of Pharmacy The Ohio State University Columbus OH USA

2. Department of Pharmaceutical Sciences Skaggs School of Pharmacy and Pharmaceutical Sciences University of Colorado Anschutz Medical Campus Aurora CO USA

3. Department of Experimental and Clinical Pharmacology College of Pharmacy University of Minnesota Minneapolis MN USA

4. Division of Clinical Pharmacology Department of Pediatrics University of Utah School of Medicine Salt Lake City UT USA

5. Projections Research Inc Phoenixville PA USA

Publisher

Wiley

Subject

Pharmacology (medical),Modeling and Simulation

Reference43 articles.

1. Guidelines for the Quality Control of Population Pharmacokinetic–Pharmacodynamic Analyses: an Industry Perspective

2. Data Quality Management in Clinical Research.https://oir.nih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/data_quality_management‐2015_05_15.pdf. Accessed April 2 2021.

3. The Simcyp®Population-based ADME Simulator

4. The influence of assay variability on pharmacokinetic parameter estimation

5. Guideline on bioanalytical method validation. In: Agency EM ed.;2012:1–23.https://www.ema.europa.eu/en/documents/scientific‐guideline/guideline‐bioanalytical‐method‐validation_en.pdf. Accessed April 2 2021.

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