• Title/Summary/Keyword: clinical therapeutics

Search Result 1,035, Processing Time 0.032 seconds

Nomenclature of emerging therapeutics in neurology

  • Shin, Jin-Hong;Park, Young-Eun;Kim, Dae-Seong
    • Annals of Clinical Neurophysiology
    • /
    • v.23 no.1
    • /
    • pp.29-34
    • /
    • 2021
  • New therapeutics in neurology are expanding at an unprecedented pace. In addition to the classic enzyme-replacement therapies, monoclonal antibodies are increasingly being used to modulate autoimmunity. RNA therapeutics are an emerging class, together with gene and cell therapies. The nomenclature of international nonproprietary names helps us to recognize these new drugs according to their class and function. Suffixes denote major categories of the drug, while infixes provide additional information such as the source and target.

The Safety and Pharmacokinetics of Cyanidin-3-Glucoside after 2-Week Administration of Black Bean Seed Coat Extract in Healthy Subjects

  • Jeon, Sang-Il;Han, Seung-Hoon;Lee, Jong-Tae;Hong, Tae-Gon;Yim, Dong-Seok
    • The Korean Journal of Physiology and Pharmacology
    • /
    • v.16 no.4
    • /
    • pp.249-253
    • /
    • 2012
  • We analyzed the pharmacokinetics of C3G on data from twelve subjects, after 2-week multiple dosing of black bean (Phaseolus vulgaris, Cheongjakong-3-ho) seed coat extract, using the mixed effect analysis method (NONMEM, Ver. 6.2), as well as the conventional non-compartmental method. We also examined the safety and tolerability. The PK analysis used plasma concentrations of the C3G on day 1 and 14. There was no observed accumulation of C3G after 2-week multiple dosing of black bean seed coat extract. The typical point estimates of PK were CL (clearance)=3,420 l/h, V (volume)=7,280 L, Ka (absorption constant)=9.94 $h^{-1}$, ALAG (lag time)=0.217 h. The black bean seed coat extract was well tolerated and there were no serious adverse events. In this study, we confirmed that a significant amount of C3G was absorbed in human after given the black bean seed coat extract.

Development of an automated appendix generation system (ARGUS) for clinical study reports

  • Jang, Doo yeon;Han, Seunghoon;Yim, Dong-Seok
    • Proceeding of EDISON Challenge
    • /
    • 2017.03a
    • /
    • pp.672-676
    • /
    • 2017
  • 데이터 처리 및 도표화는 임상 연구 보고서에 부록을 작성할 때 시간 소모적인 작업이다. 저자는 SAS (버전 9.3) 및 R (버전 3.3.1: PK 플롯 생성 용)을 사용하여 CDISC/SDTM 표준에 부합하는 자동 부록 생성 시스템 (ARGUS)을 개발했다. 이 시스템은 하나의 주 프로그램과 세 개의 서브 프로그램으로 구성되어 있다. 일반적인 데스크탑 환경에서 제출 버튼을 누른 후 약 1 분 만에 데이터베이스 파일을 MS Word 형식의 부록 문서로 변환한다. ARGUS 시스템을 사용하여 약 8일간 팀을 구성한 부록을 작성하던 작업이 6~7 시간 내에 완료되었다.

  • PDF

Mechanistic ligand-receptor interaction model: operational model of agonism

  • Kim, Hyungsub;Lim, Hyeong-Seok
    • Translational and Clinical Pharmacology
    • /
    • v.26 no.3
    • /
    • pp.115-117
    • /
    • 2018
  • This tutorial explains the basic principles of mechanistic ligand-receptor interaction model, which is an operational model of agonism. A growing number of agonist drugs, especially immune oncology drugs, is currently being developed. In this tutorial, time-dependent ordinary differential equation for simple $E_{max}$ operational model of agonism was derived step by step. The differential equation could be applied in a pharmacodynamic modeling software, such as NONMEM, for use in non-steady state experiments, in which experimental data are generated while the interaction between ligand and receptor changes over time. Making the most of the non-steady state experimental data would simplify the experimental processes, and furthermore allow us to identify more detailed kinetics of a potential drug. The operational model of agonism could be useful to predict the optimal dose for agonistic drugs from in vitro and in vivo animal pharmacology experiments at the very early phase of drug development.

The Bioequivalence of Plunazol Tablet (Fluconazole 150 mg) to Three capsules of Diflucan 50 mg (디푸루칸 캡슐 50 mg (3 캡슐, 플루코나졸 150mg)에 대한 푸루나졸 정 150mg의 생물학적 동등성)

  • Chang, Hee-Chul;Lee, Min-Suk;Ryu, Chong-Hyon;Lyu, Seung-Hyo;Cho, Sang-Heon;Choi, Yeon-Jin;Hwang, Ae-Kyung;Kim, Yun-Ah;Park, Si-Hyun;Yoon, Ji-Won;Bae, Kyun-Seop
    • Journal of Pharmaceutical Investigation
    • /
    • v.39 no.3
    • /
    • pp.207-216
    • /
    • 2009
  • Fluconazole is used as an orally administrated antifungal drug for the treatment of tinea corporis, candidiasis including skin mycotic pneumonia infections. The dosage of fluconazole varies with indication ranging from 50 mg/day to 400 mg/day. The fluconazole capsule 50 mg (3 capsules daily) is already available in Korean market. To improve the patient compliance, a fluconazole tablet 150 mg (once a day administration) was developed recently. The purpose of this study was to evaluate the bioequivalence of three doses of fluconazole capsule 50 mg (Diflucan 50 mg, Pfizer Korea Inc., as a reference drug) and a single dose of fluconazole tablet 150 mg (Plunazol 150 mg, Daewoong Pharm. Co., Korea) according to the guidelines of the Korea Food and Drug Administration (KFDA). The bioequivalence for three capsules of Diflucan 50 mg and a single tablet of Plunazol 150 mg was investigated in twenty-four healthy male volunteers under a randomized 2${\times}$2 crossover trial design. The average age of twenty-four volunteers was 24.78${\pm}$3.27 year-old, average height was 175.56${\pm}$5.45 cm and average weight was 67.24${\pm}$6.86 kg. After three capsules of Diflucan 50 mg or a single tablet of Plunazol 150 mg were orally administered, blood was taken at predetermined time intervals and the plasma concentrations of fluconazole in plasma were determined using LC-MS-MS. The 90% confidence intervals for the main parameters of statistical results after logarithmic transformation were AUCt 0.9272-1.0084 and Cmax 0.8423-0.9544 respectively, which are in the range of log 0.8 to log 1.25 and the statistical results of additional parameters (AUClast, t1/2 and MRT) were also in the 90% confidence interval that is in the range of log 0.8 to log 1.25. Therefore, the results of this study confirm the bioequivalence of three capsules of Diflucan 50 mg to one tablet of Plunazol 150 mg.

Impact of Cassia acutifolia Infusion on Glucose Levels in Obesity and Diabetes Rat Model

  • Raffoul-Orozco, Abdel Kerim;Avila-Gonzalez, Ana Elisa;Barajas-Vega, Jessica Lucia;Rodriguez-Razon, Christian Martin;Garcia-Cobian, Teresa Arcelia;Ramirez-Lizardo, Ernesto Javier;Rubio Arellano, Edy David
    • Journal of Pharmacopuncture
    • /
    • v.20 no.3
    • /
    • pp.201-206
    • /
    • 2017
  • Objectives: The aim of this study was to investigate the effects of Cassia acutifolia on the obesity and the glucose levels in a rat model of obesity and diabetes. Methods: By random selection, 36 Wistar male rats were divided in two control groups, the positive and the negative control groups, and into four experimental groups receiving different infusions of Cassia acutifolia in water ad libitum. Results: The results revealed a statistically significant anti-obesogenic effect (P = 0.02), although this was not considered clinically significant. Additionally, Cassia acutifolia lowered the glucose levels by 30 mg/dL to 90 mg/dL (P = 0.05). However, we observed adverse effects in the liver, a two-fold increase in transaminase levels (P = 0.002), and in the kidneys, decreased creatinine levels (P = 0.001), and these adverse effects had no viable explanation. Conclusion: Cassia acutifolia has anti-hyperglycemic effects in obese diabetic rats. However, Cassia acutifolia also has adverse effects, so it should not be administered to patients.