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Predicting human pharmacokinetics from preclinical data: absorption
임동석,최수인,Soo Hyeon Bae 대한임상약리학회 2020 Translational and Clinical Pharmacology Vol.28 No.3
Predicting the rate and extent of oral absorption of drugs in humans has been a challengingtask for new drug researchers. This tutorial reviews in vitro and PBPK methods reportedin the past decades that are widely applied to predicting oral absorption in humans. Thephysicochemical property and permeability (typically obtained using Caco-2 system) datais the first necessity to predict the extent of absorption from the gut lumen to the intestinalepithelium (Fa). Intrinsic clearance measured using the human microsome or hepatocytesis also needed to predict the gut (Fg) and hepatic (Fh) bioavailability. However, there aremany issues with the correction of the inter-laboratory variability, hepatic cell membranepermeability, CYP3A4 dependency, etc. The bioavailability is finally calculated as F = Fa ×Fg × Fh. Although the rate of absorption differs by micro-environments and locations in theintestine, it may be simply represented by ka. The ka, the first-order absorption rate constant,is predicted from in vitro and in vivo data. However, human PK-predicting software basedon these PBPK theories should be carefully used because there are many assumptions andvariances. They include differences in laboratory methods, inter-laboratory variances, andtheories behind the methods. Thus, the user's knowledge and experiences in PBPK and invitro methods are necessary for proper human PK prediction.
가감석홍전(加減惜紅煎)으로 호전된 궤양성대장염(潰瘍性大腸炎) 환자(患者) 치험(治驗) 1례(例)
임동석,김남욱,이형호,이영수,홍석,김희철,최창원,Lim, Dong-Seok,Kim, Nam-Uk,Lee, Hyung-Ho,Lee, Yeong-Su,Hong, Seok,Kim, Hee-Chul,Choi, Chang-Won 대한한의학방제학회 2007 大韓韓醫學方劑學會誌 Vol.15 No.1
Objective : this study is designed to evaluate the effects of an oriental medicine therapy, namely gagam-sukhongjeon, on ulcerative colitis Methods : The Clinical data was analyzed on a patient with ulcerative colitis due to hanyeolchakjab(寒熱錯雜), whose symptoms were combined chillness and fever. The patient visited at the internal medicine department of Dong-Shin University Suncheon Oriental Hospital on February 25, 2006, and go into hospital from February 25, 2006 to March 9, 2006. and revisited from March 18, 2006 to April 5, 2006. The patient was treated with Herbal medicine(gagam-sukhongjeon) Result : After treatment, bloody stool and abdominal pain disappeared in visual analogue scale(VAS), pain disability index(PDI) and verbal rating scale(VRS). Conclusions : This study suggests that gagam-Sukhongjeon is significantly effective in treatment of ulcerative colitis.
임동석,강규리,한승훈,홍태곤,전상일,백정기,강진한 연세대학교의과대학 2016 Yonsei medical journal Vol.57 No.6
Purpose: A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalentinactivated split influenza vaccine (TIV) in Korea. Materials and Methods: The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay. Results: The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI): 61.38–87.46], 72.09% (95% CI: 58.69–85.50), and 86.05% (95% CI: 75.69–96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI: 61.38–87.46), 74.42% (95% CI: 61.38–87.46), and 79.07% (95% CI: 66.91–91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited generaladverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days. Conclusion: The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial.
注音符號와 漢語倂音方案의 比較 硏究 : 現代 漢語 零聲母 表記方法을 中心으로 以現代漢語零聲母 (Zero Initial) 表記爲 中心
林東錫 건국대학교 인문과학연구소 1993 인문과학논총 Vol.25 No.-
將漢語表記的漢字爲世界上特有的表意文字. 此表意文字對於音韻表記方面, 實際上恨不方便. 故自古以來多種方法來表記漢音. 如讀若法. 雙聲疊韻法, 反切法等, 而後到近代與西方來往頻繁, 遂自然出現了用表音文字(如羅馬字) 表記漢語之方法 自民國政府設立以後, 終於認識到此事關於敎學方面及語言推行上非常重要, 於是民國初期到民國二十年(1931年) 長期間的硏究討論, 最後確定 "注音符號" (Sound -Notating Alphabet)四十一個而敎育部公布, 至今仍然使用於臺灣等地, 這是用偏旁省改的一種符號. 然1949년 在大陸中華人民共和國成立後, "文字改革, 語言必須接近民衆" 的揭旗下, 從1949年到 1957年之間, 經過多次硏究, 遂發布 "漢語倂音方案" (Chinese Phonetic System), 這是借用羅馬(Rome)字來表音漢語的方法. 現在國聯承認爲漢語倂寫的國際標準, 尊定漢語表記之基準 但兩者之間, 倂音方法若干出入, 特別零聲母倂音方法竝不相同, 注音符號乃由中國人爲了倂音自己的漢語來制造的符號, 所以其音理及寫法當然沒有特別的問題, 可是漢語倂音方案是借用근 自己不一樣的音韻體系之羅馬字來倂音漢語, 故兩者多方有所衝突. 而且其內容也比較複雜. 於是筆者在此整理其原理及情況 尤其是在韓國于敎學漢語方面, 從前皆用注音符號근威妥瑪式(T.F.Wade's System) 來表音或編字典, 而現在卽還用漢語倂音方案盛于世, 各種漢語敎材則兩者混用雜色, 敎學者必須曉得兩者之音理和倂音方法可以順通 由此, 筆者對於注音符號及漢語倂音方案, 兩者之間的音理, 制定之經緯來初步地硏究, 以供斯漢語敎學之界. 特以零聲母(Zero Initial) 表記爲中心者, 因其方法及音理較複之故也.
임동석 대한약리학회 2019 The Korean Journal of Physiology & Pharmacology Vol.23 No.4
In drug discovery or preclinical stages of development, potency parameters such as IC50, Ki, or Kd in vitro have been routinely used to predict the parameters of efficacious exposure (AUC, Cmin, etc.) in humans. However, to our knowledge, the fundamental assumption that the potency in vitro is correlated with the efficacious concentration in vivo in humans has not been investigated extensively. Thus, the present review examined this assumption by comparing a wide range of published pharmacokinetic (PK) and potency data. If the drug potency in vitro and its in vivo effectiveness in humans are well correlated, the steady-state average unbound concentrations in humans [Cu_ss.avg = f u·F·Dose/(CL· t) = f u·AUCss/t] after treatment with approved dosage regimens should be higher than, or at least comparable to, the potency parameters assessed in vitro. We reviewed the ratios of Cu_ss.avg/potency in vitro for a total of 54 drug entities (13 major therapeutic classes) using the dosage, PK, and in vitro potency reported in the published literature. For 54 drugs, the Cu_ss.avg/in vitro potency ratios were < 1 for 38 (69%) and < 0.1 for 22 (34%) drugs. When the ratios were plotted against f u (unbound fraction), “ratio < 1” was predominant for drugs with high protein binding (90% of drugs with f u ≤ 5%; i.e., 28 of 31 drugs). Thus, predicting the in vivo efficacious unbound concentrations in humans using only in vitro potency data and f u should be avoided, especially for molecules with high protein binding.