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SYSTEMES D'ADMINISTRATION TRANSDERMIQUE A PHARMACOCINETIQUE BIOEQUIVALENT A L'ADMINISTRATION ORALE
专利权人:
CORIUM INTERNATIONAL; INC.
发明人:
SINGH, PARMINDER,LEE, EUN SOO,JAIN, AMIT K.
申请号:
CA3031944
公开号:
CA3031944A1
申请日:
2017.07.26
申请国别(地区):
CA
年份:
2018
代理人:
摘要:
A method for delivering a therapeutic agent to a subject from a transdermal delivery system is described, where the therapeutic agent (i) has a half-life in the blood when delivered orally of greater than about 48 hours and (ii) is for the treatment of a chronic condition. The transdermal delivery system achieves transdermal delivery of the therapeutic agent that is bioequivalent to administration of the therapeutic agent orally, wherein bioequivalency is established by (a) a 90% confidence interval of the relative mean Cmax and AUC of the therapeutic agent administered from the transdermal delivery system and via oral delivery between 0.70 and 1.43 or between 0.80 and 1.25, or (b) a 90% confidence interval of the geometric mean ratios for AUC and Cmax of the therapeutic agent administered from the transdermal delivery system and via oral delivery between 0.70 and 1.43 or between 0.80 and 1.25.
来源网站:
中国工程科技知识中心
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