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Drug Interaction Studies: Study Design, Data Analysis, and Implications for Dosing and Labeling
Author(s) -
Huang SM,
Temple R,
Throckmorton D C,
Lesko L J
Publication year - 2007
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/sj.clpt.6100054
Subject(s) - clinical pharmacology , harmonization , food and drug administration , dosing , drug development , drug , pharmacology , business , medicine , accounting , physics , acoustics
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. Clinical Pharmacology & Therapeutics (2007) 81 , 298–304. doi: 10.1038/sj.clpt.6100054