meetings in the United States, or during scientific
advice procedures in the European Union.
Labeling
The US FDA Guidance provides specimens for
labeling. In practical terms, another useful approach
istoreviewsomerecentproductlabelsincommonly
used compendia (Physician’sDeskReference,
Drugs Sheet Compendium, Rote List, etc.) to find
the sorts of wordings that national regulatory autho-
rities have recently found to be acceptable.
Further reading
Figg WD, Dukes GE, et al.1995. Comparison of
quantitative methods to assess hepatic function:
Pugh’s classification, indocyanine green, antipyrine,
and dextromethorphan. Pharmacotherapy 165 :
693–700.
Maddrey WC, Boitnott JK,et al.1978. Corticosteroid
therapy of alcoholic hepatitis.Gastroenterology 75 :
193–199.
Pugh RNH, Murray-Lyon IM,et al.1973. Transection
of the oesopgahus for bleeding oesophageal varices.
Br. J. Surg. 60 : 646–649.
United States Food and Drug Administration. 1998.
Guidance for Industry: Pharmacokinetics in
Patients With Impaired Renal Function: Study
Design, Data Analysis and Impact on Dosing and
Labeling. US Dept Health and Human Services:
Washington; accessed March 16, 2005, from
http://www.fda.gov/cder/guidance/index.htm.
United States Food and Drug Administration. 2003.
Guidance for Industry: Pharmacokinetics in
Patients With Impaired Hepatic Function: Study
Design, Data Analysis and Impact on Dosing
and Labeling. US Dept Health and Human
Services: Washington; accessed March 16, 2005,
from http://www.fda.gov/cder/guidance/index.htm.254 CH19 HEPATIC AND RENAL FAILURE