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Is This the Dose for You?: The Role of Modeling
Author(s) -
Huang SM,
Bhattaram A,
Mehrotra N,
Wang Y
Publication year - 2013
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2012.228
Subject(s) - pharmacology , computational biology , chemistry , environmental science , medicine , biology
To make an informed benefit–risk evaluation of a drug, a range of doses needs to be evaluated and its dose–response and exposure–response relationships for safety and effectiveness assessed during drug development (International Conference on Harmonisation E4). Once a safe and effective population dose (or doses) has been determined for indicated use(s), the individual patient dose can then be adjusted based on patient‐specific factors (e.g., age, race, genetics, organ functions, concomitant medications). 1 Clinical Pharmacology & Therapeutics (2013); 93 2, 159–162. doi: 10.1038/clpt.2012.228