http://chineseinput.net/에서 pinyin(병음)방식으로 중국어를 변환할 수 있습니다.
변환된 중국어를 복사하여 사용하시면 됩니다.
2 × 2 교차설계에 의한 생물학적동등성시험에서 결측치가 있을 때의 통계적 해석 방법
박상규,이재영,최성업,윤미경,이재휘,최영욱,Park, Sang-Gue,Lee, Jae-Young,Choi, Sung-Up,Yoon, Mi-Kyeong,Lee, Jae-Whi,Choi, Young-Wook 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.5
Statistical interpretations in a bioequivalence trial are considered and studied when the missing observations occurred in $2\;{\times}\;2$ crossover experiment. Patel (1985) suggested the approximate test procedures for carryover effect and drug effect in $2\;{\times}\;2$ crossover design when some of data are missing in the second period. A modified Patel method is newly proposed to the bioequivalence trial and it is compared with the current method through the simulation study.
PLGA 미립구를 이용한 새로운 단회 접종 항원 전달 시스템의 개발
윤미경,최영욱 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.1
A promising approach to the development of a new single-step vaccine, which would eliminate the requirement for multiple injections, involves the encapsulation of antigens into microspheres. Biodegradable poly (lactide-co-gly-colide) (PLGA) microspheres gave us a bright insight for controlling antigen release in a pulsatile fashion, thereby mimicking two or three boosting injections. However, in spite of the above merits, the level of immunization induced by a single-shot vaccination is often lower than two doses of alum-adsorbed antigen. Therefore, optimal modification of the micorsphere is essential for the development of single-step vaccines. In this review, we discuss the stability of antigen in microsphere, safety and non-toxic in human and encapsulation technology. Also, we attempted to outline relevant physicochemical properties on the immunogenicity of microsphere vaccine and attainment of pulsatile release pattern by combination of different microsphere, as well as to analyze immunological data associated with antigen delivery by microsphere. Although a lot of variables are related to the optimized micorsphere formulation, we could conclude that judicious choice of proper polymer type, adjustment of particles size, and appropriate immunization protocol along with a suitable adjuvant might be a crucial factor for the generation of long-lasting immune response from a single-step vaccine formulation employing PLGA microsphere.
타가메트정 400㎎에 대한 신일시메티딘정 400㎎의 생물학적동등성시험
윤미경,이병무,이성재,김선규,이재휘,최영욱 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.6
Cimetidine is a histamine H₂-receptor antagonist, used for the treatment of endoscopically or radiographically comfirmed duodenal ulcer. pathologic GI hypersecretory conditions. and active, benign and gastric ulcer. Simple method for determining cimetidine in human plasma has been developed and validated. The analytical procedure for cimetidine showed a linear relationship in the concentration ranges from 0.05 to 5 pg/ml. Coefficient of variance (CV, ° o) for intraday and interdav validation and relative error (RE. ° o) were less than ±150 o. Based on this analytical method. the bioequivalence of two cimetidine 400 mg tablets, reference (Tagamet 400 mg) and test drug (Sinil CIMETIDINE 400 mg) was evaluated according to the guidelines set by the Korea Food and Drug Administration (KFDA). Release of cimetidine from the tablets in vitro was tested using KP VIII Apparatus II with various dissolution media (pH 1.2. 4.0. 6.8 butter solutions and water). Twenty-four healthy volunteers. 21.38±1.86 years in age and 68.71±8.68 kg in bode weight, were divided into two groups and a randomized 2x2 cross-over study was performed. After oral administration of a tablet containing 400 mg of cimetidine. blood samples were taken at predetermined time intervals and concentrations of cimetidine in plasma were determined using HPLC equipped with UV detector. The dissolution profiles of the two tablet formulations were very similar at all dissolution media. In addition. pharmacokinetic parameters such as AUC, and C_(max) were calculated and ANOVA was employed for the statistical analysis of parameters. The results were revealed that the diterences in AUCf and Cma, between the two tablets were 4.17% and 0.97% respectively. At 90% confidence intervals. the differences in these parameters were also within ± 20° o. All of the above mentioned parameters have met the criteria of KFDA guidelines for bioequivalence, indicating that the test drug tablet (Sinil CIMETIDINE tablet) is bioequivalent to Tagamet 400 mg tablet.
2×2 교차설계에 의한 생물학적 동등성 시험에서 결측치가 있을 때의 통계적 해석 방법
박상규,이재영,최성업,윤미경,이재휘,최영욱 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.5
Statistical interpretations in a bioequivalence trial are considered and studied when the missing observations occurred in 2 × 2 crossover experiment. Patel (1985) suggested the approximate test procedures for carryover effect and drug effect in 2 × 2 crossover design when some of data are missing in the second period. A modified Patel method is newly pro-posed to the bioequivalence trial and it is compared with the current method through the simulation study.
뉴로메드정(옥시라세탐 800㎎)에 대한 뉴라세탐정의 생물학적동등성
최성업,김종석,윤미경,김정일,박석,한상범,이재휘,최영욱 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.3
The purpose of the present study was designed to evaluate the bioequivalence of two oxiracetam tablets, Neuromed tablet (Korea Drug Co., reference drug) and Neuracetam tablet (Sam Jin Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Release of oxiracetam from the tablet in vitro was tested using KP Ⅷ Apparatus Ⅱ method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty-four healthy volunteers, 23.7 ± 2.4 year in age and 68.9 ± 6.2 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was performed. After oral administration of a tablet containing 800 ㎎ of oxiracetam, blood samples were taken at predetermined time intervals and concentrations of oxiracetam in plasma were determined using HPLC-MS-MS. The dissolution profiles of two formulations were very similar at all dissolution media. In addition, pharmacokinetic parameters such as AUCt, C_(max) and T_(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUC, and C_(max), untransformed T_(max). The results showed that the differences between two formulations based on the reference drug were 0.42%, 0.45% and -12.58% for AUCt, C_(max) and T_(max), respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log0.94 ~ log1.06 and log 0.90 - log 1.07 for AUCt and C_(max), respectively), indicating that Neuracetam tablet is bioequivalent to Neuromed tablet. The major pharmacokinetic parameters, AUCt, and C_(max), met the criteria set by KFDA for bioequivalence indicating that Neuracetam tablet is bioequivalent to Neuromed tablet.
건강한 한국인 성인 남성에서 레보설피리드 제제의 생체이용률
이정민,최성업,김희규,윤미경,김세희,염정록,최영욱 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.3
Pharmacokinetics and oral bioavailability of levosulpiride was determined in Korean healthy male volunteers. Thirty subjects received a single oral dose (25 ㎎) of a tablet in randomized 2×2 cross-over design. The plasma concentratons of levosulpiride were measured by HPLC and compared with those reported in the literature. Pharacokinetic parameters for Isomeric^(??) tablet (levosulpiride 25 ㎎) were revealed as follows: AUC _(inf) 737.1±176.9 ng·hr/ml, C_(max) 56.4±20.1 ng/ml, T_(max) 4.2±1.6hr, K_(a) 1.00±1.09 hr^(-1), K_(el) 0.08±0.02 hr^(-1), and t_(1/2) 8.8±1.9 hr. The rate constant of the absorption phase was obtained based on the first-order kinetics. In the aspect of bioavailability, Isomeric^(??) tablet was bioequivalent to the other product (Levopride^(?)tablet) available in the Korean market. Intersubject variations and race differences were shown in comparison with the published date in the literature, even though there ws a linear relationship between dose and extent of bioavailability.