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Clin Pharmacol Ther. 2007 Feb;81(2):298-304.

Drug interaction studies: study design, data analysis, and implications for dosing and labeling.

Author information

1
Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. shiewmei.Huang@Fda.hhs.gov

Abstract

One of the most effective ways in which regulatory agencies communicate with sponsors and guide drug development is through the issuance of guidances or guidelines. These can be issued domestically in a given region such as the United States by the Food and Drug Administration (FDA) or internationally through the International Conference on Harmonization. Currently, there are over 400 final or draft guidances that can be found through the FDA website. The development of guidances proceeds through a process known as Good Guidance Practices, which is intended to assure that there is an appropriate level of meaningful public participation in the development of guidance. In the past 10 years, clinical pharmacology guidances covering important areas have been issued, including pharmacokinetic data in patients with renal and hepatic impairment, dose-response studies, and drug-drug interactions.

PMID:
17259955
DOI:
10.1038/sj.clpt.6100054
[Indexed for MEDLINE]

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