생몰정보
소속
직위
직업
활동분야
주기
서지
국회도서관 서비스 이용에 대한 안내를 해드립니다.
검색결과 (전체 1건)
원문 있는 자료 (1) 열기
원문 아이콘이 없는 경우 국회도서관 방문 시 책자로 이용 가능
목차보기더보기
title page
Contents
List of abbreviations 11
(Abstract) 12
I. Introducton 15
II. Materials and methods 22
1. Materials 22
A. Chemicals and reagents 22
B. Instruments 22
C. Subjects 26
2. Methods 27
A. Pilot dose duration-response study 27
B. Pivotal in vivo bioequivalence study 31
C. Skin stripping study 33
1) Assay validation of desonide 33
a) Specificity 33
b) Sensitivity 33
c) Linearity 33
d) Precision and accuracy 33
e) Recovery 34
2) Experimental design 36
D. Statistical analysis 37
1) Pilot dose duration-response study 37
2) Pivotal in vivo bioequivalence study 38
3) Skin stripping study 40
III. Results 41
1. Pilot dose duration-response study 41
2. Pivotal in vivo bioequivalence study 51
3. Skin stripping study 59
A. Assay validation of desonide 59
1) Specificity 59
2) Sensitivity 59
3) Linearity 59
4) Precision and accuracy 59
5) Recovery 60
B. Skin stripping study results 65
IV. Discussion 71
V. Conclusion 75
VI. References 76
(국문초록) 80
Acknowledgements 84
Table 1. Potency ranking of selected topical corticosteroids. 19
Table 2. HPLC conditions for the analysis of desonide in tape-strips. 25
Table 3. Chromameter a*scale raw data and baseline-adjusted, untreated control site-corrected a*scale data for a subject in the pilot dose duration-response study. 43
Table 4. △a*AUEC(0-24 hr(이미지참조)) data for 12 subjects in the pilot dose duration-response study. 44
Table 5. △a*, △L*, △b*, △E data and △E AUEC data for a subject. 45
Table 6. △E AUEC(0-24 hr(이미지참조)) data for 12 subjects in the pilot dose duration-response study. 46
Table 7. Emax model parameter estimates based on population analyses with △a*AUEC(0-24 hr) and △E AUEC(0-24 hr) data by NONMEM and WinNonlin program.(이미지참조) 49
Table 8. Emax model parameter estimates based on individual analysis with △a*AUEC(0-24 hr) data and △E AUEC(0-24 hr) data by WinNonlin program.(이미지참조) 50
Table 9. Chromameter a*scale raw data and baseline-adjusted, untreated control site-corrected a*scale data for a subject in the pivotal in vivo bioequivalence study. 52
Table 10. △a*, △E data and △a*AUEC, △E AUEC data for a subject in the pivotal in vivo bioequivalence study(표없음) 7
Table 11. △a*AUEC(0-24 hr) and △E AUEC(0-24 hr) data for the two arm average at dose duration D₁, D₂, and the ratio of average AUEC(0-24 hr) at D₂/average AUEC(0-24 hr) at D₁ of all 40 subjects in the pivotal in vivo bioequivalence study.(이미지참조) 54
Table 12. △a*AUEC(0-24 hr) and △E AUEC(0-24 hr) data for two arms average of all 40 subjects at dose duration of 2 hr and 90% CIs for detectors in the pivotal in vivo bioequivalence study.(이미지참조) 55
Table 13. Locke’s method for calculating confidence interval from △a*AUEC(0-24 hr(이미지참조)) data of 13 detectors in the bioequivalence study. 56
Table 14. Locke’s method for calculating confidence interval from △E AUEC(0-24 hr(이미지참조)) data of 18 detectors in the bioequivalence study. 57
Table 15. Precision and accuracy of HPLC analysis of desonide in tape-stripped SC samples. 63
Table 16. Relative recoveries of desonide for tape-stripped SC samples. 64
Figure 1. Chemical structures of desonide (A) and butyl 4-hydroxybenzoate (IS)(B). 24
Figure 2. Staggered application with synchronized removal method [FDA Guidance, 1995]. 29
Figure 3. Representative treatment administration schematics in the pilot dose duration-response study. Twenty microliter aliquots (5 μg of desonide/cm²) were applied to 2-cm² application sites on the both ventral forearms of each subject [Tsai et al., 2004]. 30
Figure 4. Representative treatment administration schematics in the pivotal in vivo bioequivalence study. 32
Figure 5. Observed △a*AUEC(0-24 hr) data for each subject (filled circle), and Emax model fitted(black line) to the pooled dose duration-response data of all 12 subjects in the pilot dose duration-response study.(이미지참조) 47
Figure 6. Observed △E AUEC(0-24 hr) data for each subject (filled circle), and Emax model fitted(black line) to the pooled dose duration-response data of all 12 subjects in the pilot dose duration-response study.(이미지참조) 48
Figure 7. 90% confidence intervals from Locke’s method in the bioequivalence study. 58
Figure 8. Chromatograms of blank tape-stripped SC (A), tape-stripped SC sample spiked with desonide (0.4 μg/ml) and internal standard (IS, butyl 4-hydroxybenzoate 0.5 ㎍/ml) (B), and tape-stripped at SC sample at a dose duration of 2 hr(C). 61
Figure 9. Calibration curve of desonide in tape-stripped SC samples. 62
Figure 10. Correlation between desonide amount in 10 tape-strips and BL-adjusted, untreated control site-corrected a*scales. 66
Figure 11. Correlation between dose duration and desonide amount in 10 tape-strips. 67
Figure 12. Correlation between dose duration and baseline-adjusted, untreated control site-corrected a*scales. 68
Figure 13. Correlation among the dose duration, desonide in 10 tape-strips, and baseline-adjusted, untreated control site-corrected a*scales. 69
Figure 14. Correlation among the dose duration, desonide amount in 10 tape-strips, and △E values. 70
Scheme 1. Extraction procedures for the HPLC analysis of desonide in the tape-strips. 35
원문구축 및 2018년 이후 자료는 524호에서 직접 열람하십시요.
도서위치안내: / 서가번호:
우편복사 목록담기를 완료하였습니다.
* 표시는 필수사항 입니다.
* 주의: 국회도서관 이용자 모두에게 공유서재로 서비스 됩니다.
저장 되었습니다.
로그인을 하시려면 아이디와 비밀번호를 입력해주세요. 모바일 간편 열람증으로 입실한 경우 회원가입을 해야합니다.
공용 PC이므로 한번 더 로그인 해 주시기 바랍니다.
아이디 또는 비밀번호를 확인해주세요
