Affordable Access

Hemodynamic surrogate end-points in phase I studies?

Authors
  • De Mey, C
Type
Published Article
Journal
International journal of clinical pharmacology and therapeutics
Publication Date
Apr 01, 1997
Volume
35
Issue
4
Pages
175–179
Identifiers
PMID: 9112140
Source
Medline
License
Unknown

Abstract

Clinical pharmacology studies in healthy volunteers ("human pharmacology studies") characterize the pharmacokinetic and pharmacodynamic hallmarks of pharmacological action and their interrelation in the intact effector system unconfounded by disease and comedication. They constitute a valuable basis for the subsequent explicit investigation of the clinical efficacy, safety, efficiency, and therapeutic benefit in patients, but are not a valid surrogate for them.

Report this publication

Statistics

Seen <100 times