Do we need highly sensitive analytical techniques in phase I?
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.
Singlas
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Pharmacie Clinique, CHU Bicĕtre, Le Kremlin Bicêtre, France.
D002623:Chemistry Techniques, Analytical; D004341:Drug Evaluation / Q000379:methods*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis*; D010599:Pharmacokinetics
D004364:Pharmaceutical Preparations