OBJECTIVE: First-in-human dose estimation is an essential approach for successful clinical trials for drug development. In this study, we systematically compared first-in-human dose and human pharmacokinetic parameter estimation approaches. METHODS: First-in-human dose estimation approaches divided into similar drug comparison approaches, regulatory guidance based approaches, and pharmacokinetic based approaches. Human clearance, volume of distribution and bioavailability were classified for human pharmacokinetic parameter estimation approaches. RESULTS: Similar drug comparison approaches is simple and appropriate me-too drug. Regulatory guidance based approaches is recommended from US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding no-observed-adverse-effect level (NOAEL) or minimum anticipated biological effect level (MABEL). Pharmacokinetic based approaches are 8 approaches for human clearance estimation, 5 approaches for human volume of distribution, and 4 approaches for human bioavailability. CONCLUSION: This study introduced and compared all methods for first-in-human dose estimation. It would be useful practically to estimate first-in-human dose for drug development.
Biological Availability ; Humans ; No-Observed-Adverse-Effect Level ; Pharmacokinetics ; United States Food and Drug Administration

No abstract available.
Scalp* ; Skin* ; Transplants*

No abstract available.
Cleft Lip* ; Congenital Abnormalities*

BACKGROUND: Glutamate is implicated in the pathophysiology of migraine, a common neurological disorder. Therefore, glutamate receptor antagonists (GluRAs) have been suggested as a novel migraine treatment that are able to overcome the limitations of triptans. OBJECTIVE: The aim of this study was to perform a meta-analysis to assess the efficacy of GluRAs for patients with migraine. Method: The PubMed, Cochrane Library, CINAHL, and Clinical Trial.gov databases were searched for randomized placebo-controlled trials of the efficacy of GluRAs for patients with migraine conducted up to August 2019. Two independent reviewers screened the literature according to inclusion and exclusion criteria and performed quality assessment and data extraction. Review Manager 5.3 software was used for the meta-analysis. RESULTS: Three studies involving a total of 206 patients were included in the final analysis. Compared with placebo, GluRAs significantly improved the pain-free response at 2 hours (odds ratio [OR]=3.85, 95% confidence intervals [CIs]=1.63–9.09) and the 24-hour sustained pain freedom (OR=7.40; 95% CIs=2.36–23.20). The use of rescue medications with GluRAs was lower compared to that with placebo, but the difference was not significant (OR=0.39, 95% CI=0.10–1.47). CONCLUSION Our meta-analysis showed that GluRAs were more effective than placebo for patients with migraine.

No abstract available.
Suction* ; Tonsillectomy*

OBJECTIVE: Atrial fibrillation (AF) guidelines have been published in the USA and Europe. Recently, the USA and Europe have updated their guidelines, respectively. These new AF guidelines help in addressing key management issues in clinical situations. This study, therefore, systematically compared guidelines for rate and rhythm control pharmacotherapy of patients with AF between the USA (American College of Cardiology and American Heart Association, ACC/AHA) and Europe (European Society of Cardiology, ESC). METHODS: This study investigated and compared American guidelines (2014) and European guidelines (2010 and 2012). RESULTS: Generally, there are four meaningful differences between ACC/AHA and ESC guidelines. Important differences are treatment classification system, level of recommendation, drug list, and dosage. In addition, ACC/AHA described pharmacokinetic drug interactions for antiarrhythmic drugs. ESC emphasized ECG and atrioventricular nodal slowing as feature of antiarrhythmic drugs. CONCLUSION: This research addresses important use of anti-arrhythmic drugs and movement to accept recent recommendations in Korea. For the successful application of the guidelines, a role of pharmacists is crucial in clinical situation.
American Heart Association ; Anti-Arrhythmia Agents ; Atrial Fibrillation* ; Cardiology ; Classification ; Drug Interactions ; Drug Therapy* ; Electrocardiography ; Europe* ; Humans ; Korea ; Pharmacists

OBJECTIVE: International institutes such as Global institute for Asthma(GINA), KAAACI(Republic of Korea), NHLBI(USA), BTS(UK) and JSA(Japan) have published guidelines for asthma treatment. The aim of this study was to compare the representatives' international guidelines of pharmacotherapy for pediatric asthma. METHODS: The recommendations related to pharmacotherapy for pediatric asthma were extracted from the latest representatives' international guidelines, and comprehensive comparisons were conducted. RESULTS: Major comparison outcomes between international guidelines were evaluated as follows: classification system on severity and pediatric age group, recommendation for inhaled corticosteroid dose, recommendation for pediatric age group of theophylline in mild asthma, and recommendation for pediatric age group of tiotropium in severe asthma. Clinical trials emphasized the adverse effects of theophylline, whereas tiotropium demonstrated beneficial actions for pediatric asthma. Therefore, theophylline was recommended for older patients with persistent asthma, and tiotropium was considered to be suitable for younger patients with severe asthma according to GINA guidelines. CONCLUSION: These findings address the requirement to harmonize international guidelines of pharmacotherapy in pediatric asthma. In addition, the findings suggest that KAAACI needs to update its pharmacotherapy guidelines of theophylline, tiotropium and other medicines recently approved.
Academies and Institutes ; Asthma* ; Classification ; Drug Therapy* ; Humans ; Pediatrics ; Theophylline ; Tiotropium Bromide

No abstract available.
Hand* ; Skin* ; Transplants*

No abstract available.
Durapatite* ; Forehead*

OBJECTIVE: Patients with acute coronary syndrome (ACS) are typically managed with dual antiplatelet therapy of acetylsalicylic acid (aspirin) and P2Y12 receptor inhibitor. In this study, we discussed current and previous antiplatelet therapy guidelines and compared with guidelines of the USA (ACC/AHA), Europe (ESC) and Korea (KSC). METHOD: This study investigated from ACC/AHA Joint Guidelines (the USA), ESC Clinical Practice Guidelines (Europe) and Korea Society of Interventional Cardiology (Korea) web site, respectively. RESULTS: It is significant that difference between the current and the previous guidelines was integration of terminology from clopidogrel to P2Y12 receptor inhibitors since prasugrel and ticagrelor, new antiplatelet drugs, has been added. The other difference was all three guidelines has differences in dose of aspirin. The most notable difference was class of recommendation (COR) in P2Y12 receptor inhibitors. ACC/AHA and Korean guidelines recommend clopidogrel, prasugrel, and ticagrelor with COR IB; whereas, ESC recommend prasugrel and ticagrelor with IB which is higher than clopidogrel with IC. CONCLUSION: This research addresses important movement to revise the Korean existing guideline recommendations. New Korean antiplatelet therapy guideline should be avoiding obvious differences in ACC/AHA and ESC guidelines and harmonizing international guidelines.
Acute Coronary Syndrome* ; Aspirin ; Cardiology ; Europe* ; Humans ; Joints ; Korea* ; Prasugrel Hydrochloride