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니코틴 패취제의 생물학적 동등성 평가
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  • 니코틴 패취제의 생물학적 동등성 평가
  • Bioequivalence of Nicotine Patches
저자명
배준호,박은석,지상철
간행물명
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
권/호정보
1997년|5권 3호|pp.260-264 (5 pages)
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한국응용약물학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The bioequivalence of two nicotine patches was evaluated in 16 normal male volunteers (age 21 ~ 27 yrs) following single transdermal application. Test product was "Nicostop patch" made by Sam Yang Co. and reference product was "Nicotinell TTS patch" made by Korean Searle Ciba-Geigy Co. After nicotine patches were applied onto the inside of the forearm, blood was taken at predetermined time intervals and the nicotine concentration in plasma was determined with a sensitive GC method using NPD detector. AUC and Cmulcorner were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC and $C_{msx}$between two products were 5.47% and 2.70%, respectively. The powers (1-$eta$) for AUC and $C_{max}$. were >90% and 88.76%, respectively. Detectable differences($Delta$) and confidence intervals were all less than 20%. All of these parameters met the criteria of KFDA for bioequivalence, indicating that "Nicostop patch" is bioequivalent to "Nicotinell TTS patch" . . .