Concepedia

Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions

Joo Yeon Lee, Christine Garnett, Jogarao Gobburu, Venkatesh Atul Bhattaram, Satjit Brar, Justin Earp, Pravin Jadhav, Kevin Krudys, Lawrence J. Lesko, Fang Li,

Clinical Pharmacokinetics · 2011 · 148 citations · 5 references

DOI

Concepts

References

5

Impact of Pharmacometric Reviews on New Drug Approval and Labeling Decisions—a Survey of 31 New Drug Applications Submitted Between 2005 and 2006

Venkatesh Atul Bhattaram, Charles R. Bonapace, Dakshina Chilukuri et al. · Clinical Pharmacology & Therapeutics · 2007 · 118 citations

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Population Pharmacokinetic–Based Dosing of Intravenous Busulfan in Pediatric Patients

Brian Booth, Atiqur Rahman, Ramzi Dagher et al. · The Journal of Clinical Pharmacology · 2006 · 98 citations

, , +16

Pharmacokinetic and Pharmacodynamic Basis for Effective Argatroban Dosing in Pediatrics

Rajanikanth Madabushi, Donna S. Cox, Mohammad Sharif Hossain et al. · The Journal of Clinical Pharmacology · 2010 · 64 citations

, , +16

Pharmacometrics-Based Dose Selection of Levofloxacin as a Treatment for Postexposure Inhalational Anthrax in Children

Fang Li, Partha Nandy, Shuchean Chien et al. · Antimicrobial Agents and Chemotherapy · 2009 · 40 citations · Full text

, , +17

Optimising piperacillin/tazobactam dosing in paediatrics

Christoffer W. Tornøe, Jeffrey J. Tworzyanski, Menfo A. Imoisili et al. · International Journal of Antimicrobial Agents · 2007 · 32 citations

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