Drug Development Perspective on Pharmacokinetic Studies of New Drugs in Patients With Renal Impairment.
- Resource Type
- Article
- Authors
- Lalonde, R. L.; Wagner, J. A.
- Source
- Clinical Pharmacology & Therapeutics; Nov2009, Vol. 86 Issue 5, p557-561, 5p, 1 Diagram, 2 Charts, 1 Graph
- Subject
- DRUG development
PHARMACOKINETICS
KIDNEY diseases
CLINICAL trials
DRUG dosage
- Language
- ISSN
- 00099236
The article presents the authors' insight regarding drug development on pharmacokinetic (PK) studies involving patients with renal impairment. They discuss the possible alteration of PK of drugs by severe renal impairment. They recommend that the various PK data from patients with different degrees of renal impairment and from different clinical trials should be the basis for dosage recommendations in renal impairment. They suggest the continued use of traditional equations in drug development.