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Do we need highly sensitive analytical techniques in phase I?
Author(s) -
Singlas E.
Publication year - 1990
Publication title -
fundamental and clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.655
H-Index - 73
eISSN - 1472-8206
pISSN - 0767-3981
DOI - 10.1111/j.1472-8206.1990.tb00071.x
Subject(s) - pharmacokinetics , dosing , clinical trial , drug , pharmacology , regimen , medicine , drug development , phases of clinical research , phase (matter) , intensive care medicine , chemistry , organic chemistry
Summary— Pharmacokinetic studies constitute part of phase I clinical trials. Initiation of dosage regimen in phase II and III clinical trials depends on drug pharmacokinetics and the choice of dosing interval relies on the elimination rate constant. Consequently, inaccurate determination of these parameters can lead to unexpected drug levels and side‐effects in patients and can delay the clinical development of the drug.