Drug interaction studies: study design, data analysis, and implications for dosing and labeling
用户bEcv-rzIERoU
4天前
33
10
已关闭
DOI:
文献链接:
其他信息:
SM Huang, R Temple…
Clinical …, 2007
Wiley Online Library
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 …
