1. Do we need highly sensitive analytical techniques in phase I?
- Author
-
Singlas E
- Subjects
Pharmacology ,Drug ,medicine.medical_specialty ,business.industry ,media_common.quotation_subject ,food and beverages ,Chemistry Techniques, Analytical ,Highly sensitive ,Clinical trial ,Regimen ,Pharmacokinetics ,Elimination rate constant ,Pharmaceutical Preparations ,Medicine ,Drug Evaluation ,Humans ,Pharmacology (medical) ,Dosing interval ,In patient ,business ,Intensive care medicine ,media_common - Abstract
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.
- Published
- 1990