- 유사인자를 사용하여 용출양상 유사성을 비교하는 방법에 대한 고찰
- ㆍ 저자명
- 조미현,김정호,이현태,사홍기,Cho. Mi-Hyun,Kim. Jeong-Ho,Lee. Hyeon-Tae,Sah. Hong-Kee
- ㆍ 간행물명
- 藥劑學會誌
- ㆍ 권/호정보
- 2003년|33권 3호|pp.245-253 (9 pages)
- ㆍ 발행정보
- 한국약제학회
- ㆍ 파일정보
- 정기간행물| PDF텍스트
- ㆍ 주제분야
- 기타
Dissolution profile comparsions can be done by virtue of the similarity factor $(f_2)$. It is a logarithmic reciprocal square root transformation of the sum of squared error of % dissolution differences between two profiles at several time points. It gives information on the degree of similarity between the two profiles: An $f_2$ value between 50 and 100 suggests the similarity/equivalence of the two dissolution curves being compared. The objective of this report was to provide a careful examination on the $f_2$ metrics in detail. It was shown that $f_2$ values exceeded 50, when relative differences in % dissolved between two products were less than 15% at all time points. The similarity factor value was also found to be greater than 50, in cases when absolute % dissolution differences were below 10% at all time points. Interestingly, the $f_2$ value was changed by the number of the time points selected for calculation. In particular, $f_2$ tended to have higher values, when the $f_2$ metrics used a large number of time points in which % dissolved reached plateau. Finally, since the similarity factor was a sample statistics, it was impossible to infer type I/II errors and sampling error. Despite certain limitations inherited in the $f_2$ metrics, it was easy and convenient to evaluate how similar the two dissolution profiles were.