Deflazacort, an oxazoline derivative of prednisolone, has been claimed to have anti-inflammatory effects with fewer side effects compared to prednisone. The objectives of the study were to evaluate efficacy and safety of deflazacort in children with nephrotic syndrome. Eligible Patients were the children with nephrotic syndrome who were treated with deflazacort from October. 1994 to April. 1999. Nephrotic syndrome was defined as having albumin level of less than 2.5 mg/dL and 24-hour urinary protein excretion of greater than $40\;mg/m^2/hr$. The primary parameters evaluating the efficacy of deflazacort were response rate, time to respond and relapse frequency. The safety profiles were the impact on children's growth, calcium sparing effect, glucose metabolism, lipid profile and adverse drug reactions. As results, total of 60 children were evaluated (47 boys, 13 girls). Response rate was $95\%$ (57/60) for initial and late responders. Median time to respond was 12 days (range 7-110 days) and median relapse frequency was one time (range 0-6). Weight/height ratio increased from $22.05\pm3.47\;to\23.20\pm3.44\;kg/m$ (p<0.001) and plasma calcium level, from $7.55\pm3.86\;to\;9.98\pm3.77\;mg/dL$ after treatment (p<0.001). Change of fasting glucose level was not statistically significant $(91.92\pm3.53\;vs.\;98.19\pm4.78\;mg/dL,\;p=0.072)$, while change of total cholesterol was significant $(362.3\pm12.0\;vs\;251.4\pm11.5\;mg/dL$, p<0.001). In conclusion, patients on deflazacort showed similar efficacy in treatment of nephrotic syndrome as reported for prednisone with less impact on growth inhibition and metabolic side effects of hyperglycemia and hyperlipidemia.

Gastrointestinal (GI) medications have been administered to many patients without any gastrointestinal diseases. The objectives of this study were to evaluate use of GI drugs and assess related factors. Medical records of 600 outpatients were reviewed from January 1997 to December 1997 at A Hospital, Kyunggi-do, Korea. Fifty patients every month among all outpatients were randomly selected up to total 600 patients. Surgical patients, visitors for regular health examination and inpatients were excluded. GI symptoms included nausea, vomiting, diarrhea, dyspepsia, constipation, heartburn, dysphagia and abdominal pain. The prescribed gastrointestinal drugs were antacids. $H_2$-antagonist, sucralfate, cisapride, omeprazole, laxatives, digestive enzymes and antidiarrheal agents. Patients without GI symptoms were 348 out of 600 outpatients who were screened. Two hundred and eighty two of 348 patients $(81\%)$ were given GI drugs though they did not have any GI symptoms. There were no differences in regard to sex and age of patients. Most of medical departments prescribed gastrointestinal drugs for these patients. The most frequently prescribed drugs were in order of digestive enzyme, antacids and $H_2$-antagonists. In view of economic aspects, patients paid 12.28 percents of total cost per prescription for unnecessary medicines. The medical practice of prescribing GI drugs should be assessed to define appropriate subgroups to have benefits with prophylactic administration and to reduce adverse effects caused by drug interactions. Pharmacists would have a significant role to promote rational drug therapy.

Terbinafine has a primary fungicidal action mediated by squalene epoxidase inhibition. Treated fungi accumulate squalene while becoming deficient in ergosterol, an essential component of fungal cell membranes. Bioequivalence of two terbinafine tablets, $Lamisil^{TM}$ (Novartis Korea Ltd., Seoul, Korea) and $Mycosil^{TM}$ (Daewon Pharmaceutical Co., Ltd., Seoul, Korea), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers ($20\sim29$ years old) were randomly divided into two groups and a randomized $2\times2$ cross-over study was employed. After oral administration of $Mycosil^{TM}\;or\;Lamisil^{TM}$ (125 mg terbinafine), blood samples were taken at predetermined time intervals and the serum terbinafine concentrations were determined using an HPLC method with UV/VIS detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and ANOVA was utilized for the statistical analysis. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on the $Lamisil^{TM}$ tablet were $-2.24\%,\;-7.68\%\;and\;2.92\%$, respectively. The powers %(1-\beta)\;for\;AVC_t,\;C_{max}\;and\;T_{max}\;were\;87.11\%,\;95.36\%\;and\;99.99\%$, respectively. Minimum detectable differences $(\Delta)\;and\;90\%$ confidence intervals were all less than $\pm20\%$. All these parameters met the criteria of KFDA for bioequivalence, indicating that $Mycosil^{TM}$ tablet is bioequivalent to $Lamisil^{TM}$ tablet.

The bioequivalence of two omeprazole preparations was evaluated following their oral administration to 16 normal volunteers. The test product was 'Ulpro tablet' made by Boryung Pharmaceutical Co. and the reference was 'Losec capsule' made by Yuhan Corp. After one capsule or tablet containing 20 mg omeprazole was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was determined with an HPLC method. AUC and $C_{max}$ were determined and analyzed statistically for the evaluation of bioequivalence of the two products. The differences in AUC and $C_max$ between two products were $0.45\%\;and\;2.83\%$, respectively. The powers for AUC and $C_{max}\;were\;89.2\%\;and\;>90\%$, respectively. Confidence intervals were within $20\%$ for AVC and $C_{max}$All of these parameters met the criteria of KFDA for bioequivalence, indicating that 'Ulpro tablet' is bioequivalent to 'Losee capsule.'

Y-Site 투여시 $5\%$포도당액과 생리식염수에서 탁솔과 은단세트론의 안정성에 관해 실온과 형광등 아래서 연구하였다. 온단세트론 0.03 mg/ml, 0.1 mg/ml, 0.3 mg/ml와 탁솔 0.3 mg/ml, 1.2mg/ml를 각각 1:1로 혼합한 후 0, 1, 2, 4, 12시간에서 즉시 약물농도를 HPLC로 분석하였다. 방해물질에 의한 분석오차를 줄이기 위해 분석법을 여러상태에서 확인하였으며, 각 농도에서 3차례씩 실험하였고 각 샘플은 2차례 연속 HPLC 분석하였다. 분석전에 각 시료의 투명도, 색의변화, 침전상태 및 pH를 검사하였다. 온단세트론 0.03, 0.1 및 0.3 mg/ml와 탁솔 0.3 및 1.2mg/ml를 각각 혼합하였을 때 12시간 동안 안정성이 있었다. 혼탁이나 색의 변화 및 침전은 나타나지 않았으며 12시간 동안 pH의 변화는 특별한 경향이 없었다.