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Bioequivalence Study Comparing a Generic and Innovator Drug of Rosuvastatin 20 mg 瑞舒伐他汀20mg仿制药与创新药的生物等效性研究
Pub Date : 2023-01-04 DOI: 10.23880/beba-16000189
Dewi Ou
The bioequivalence study was conducted to compare the bioavailability of two rosuvastatin 20 mg film-coated tablet formulations (test and reference formulation). This study was an open-label, randomized, single-dose, two-periods, twotreatments, and crossover study which included 32 healthy adult male and female subjects under fasting conditions. Each of the two study periods was separated by a 7 days washout period. A single oral dose of test or reference drug was administered to the subject in each period based on the randomization scheme. Plasma concentrations of the drug were determined by LC-MS/MS method. The pharmacokinetic parameters assessed in this study were the area under the plasma concentration-time curve from time zero to 72 h (AUC0-72h), area under the plasma concentration-time curve from time zero to infinity (AUC0-∞), the peak plasma concentration of the drug (Cmax), time needed to achieve the peak plasma concentration (Tmax), and the elimination half-life (T1/2). The geometric mean ratio (GMR) and 90% Confidence Interval (90% CI) for AUC0-72h and Cmax of test/reference drug for rosuvastatin were 97.05 % (89.07%– 105.74%) and 101.15% (89.53%– 114.26%). Since the 90% CI with α 0.05% for AUC0-72h and Cmax of rosuvastatin were within the standard bioequivalence range (80.00– 125.00%), it was concluded that the two rosuvastatin film-coated tablets (test and reference drug) were bioequivalence in terms of the rate and extent of absorption.
采用生物等效性研究比较两种瑞舒伐他汀20mg薄膜包衣片制剂(试验制剂和参比制剂)的生物利用度。该研究是一项开放标签、随机、单剂量、两期、两种治疗和交叉研究,包括32名禁食条件下的健康成年男性和女性受试者。两个研究期之间分别有7天的洗脱期。根据随机方案,受试者在每个时期口服单剂量的试验药物或参考药物。采用LC-MS/MS法测定药物的血药浓度。本研究评估的药代动力学参数为:时间0-72h的血药浓度-时间曲线下面积(AUC0-72h)、时间0-∞的血药浓度曲线下面积(AUC0-∞)、药物的血药浓度峰值(Cmax)、达到血药浓度峰值所需时间(Tmax)、消除半衰期(T1/2)。瑞舒伐他汀的AUC0-72h的几何平均比(GMR)和90%置信区间(90% CI)分别为97.05%(89.07% ~ 105.74%)和101.15%(89.53% ~ 114.26%)。在AUC0-72h内,瑞舒伐他汀的90% CI (α 0.05%)和Cmax均在标准生物等效范围内(80.00 ~ 125.00%),说明两种瑞舒伐他汀薄膜包衣片(受试药和参比药)在吸收速率和吸收程度上具有生物等效性。
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引用次数: 0
Bioavailability – Challenges and Advances in Drug Targeting 生物利用度-药物靶向的挑战和进展
Pub Date : 2023-01-04 DOI: 10.23880/beba-16000186
V. M.
It has been a very challenging task in drug development to handle bioavailability of drug molecules during targeting. Foremost challenges include the time span involved apart from various complexities, wrong methods or failure in outcome, increasing manual and financial requirements to be managed in the drug discovery process. Among this bioavailability is one of the biggest challenges handled to successfully identify druggability in a molecule. Various methods of administration and targeting has been used including co-crystallization, micro emulsion, micellar solubilization and other traditionally which has also expanded to other methods as morphous solid dispersion, liposomes, and complexions. To enable precision in availability of drug molecule at the targeted site. There has been an increase in bioavailability of potential drugs. This review comprehensively determines challenges and methods used in drug targeting based on their bioavailability.
在药物靶向过程中如何处理药物分子的生物利用度一直是药物开发中一个非常具有挑战性的课题。最重要的挑战包括除了各种复杂性之外所涉及的时间跨度,错误的方法或结果失败,在药物发现过程中需要管理的人工和财务需求增加。在这种生物利用度是最大的挑战之一处理成功识别药物的分子。各种给药和靶向方法已被使用,包括共结晶、微乳液、胶束增溶和其他传统的方法,也已扩展到其他方法,如形态固体分散体、脂质体和显色剂。使药物分子在靶部位的可用性精确。潜在药物的生物利用度有所提高。这篇综述全面确定了基于生物利用度的药物靶向的挑战和方法。
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引用次数: 0
Evaluation of the Participation of Phenolic Compounds Naturally Present in Food in Stimulating the Health of the Organism 评价食品中天然存在的酚类化合物对促进机体健康的作用
Pub Date : 2023-01-04 DOI: 10.23880/beba-16000187
Mancini-Filho J
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引用次数: 0
A Mini Review on Bioequivalence & the Bioavailability Study on Anticancer Drugs 抗癌药物生物等效性及生物利用度研究综述
Pub Date : 2023-01-04 DOI: 10.23880/beba-16000188
Behera A
Bioavailability has been one of the most important properties for the formulation to be an effective. The poor oral bioavailability and solubility of several anti-cancer drugs has challenged the scientists all over the world to think differently than the traditional drug delivery system. Recently, the use of natural polymer has been increased to increase the bioavailability of these drugs. Casein polymer has shown to be promising in increasing the bioavailability of the anticancer drugs due to its amphiphilic nature which can bind both hydrophilic and hydrophobic drugs. Due to the nature of the casein it has drawn the attention of the scientists all over the world. In this review, we have focused on the work of various scientists in increasing the oral bioavailability of poorly bioavailable anticancer drugs.
生物利用度一直是制剂是否有效的最重要的特性之一。一些抗癌药物的口服生物利用度和溶解度较差,这对世界各地的科学家提出了挑战,要求他们与传统的给药系统进行不同的思考。近年来,为了提高这些药物的生物利用度,越来越多地使用天然聚合物。酪蛋白聚合物具有两亲性,可结合亲水和疏水药物,在提高抗癌药物的生物利用度方面具有广阔的应用前景。由于酪蛋白的性质,它引起了全世界科学家的注意。在这篇综述中,我们重点介绍了各种科学家在提高生物利用度差的抗癌药物的口服生物利用度方面的工作。
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引用次数: 0
Covid-19 Vaccinations and Menstrual Cycle Alteration Covid-19疫苗接种与月经周期改变
Pub Date : 2023-01-04 DOI: 10.23880/beba-16000182
Hussain S
The rapid development of safe and effective vaccines against Coronavirus Disease 2019 (COVID-19) has been a triumph of medical sciences, but vaccines only work if people take them. COVID-19 vaccination may be associated with change in menstrual cycle length following vaccination. Although there is extensive evidence that COVID-19 vaccination does not affect fertility, misinformation that it could has been a major source of vaccine hesitancy among young women. As the vaccination program was rolled out to younger age groups, some people noticed menstrual changes after COVID-19 vaccination, and many members of the public found these reports concerning. Research was needed to generate robust data to inform healthcare professionals and the public about these potential side effects. Menstrual changes have been reported in association with a variety of vaccines, including those against pathogens other than severe acute respiratory syndrome coronavirus 2 (SARSCoV-2), so the aim of this work is to describe SARS-CoV-2 infection and the menstrual cycle changes because of it.
快速开发出安全有效的2019冠状病毒病(COVID-19)疫苗是医学的一大胜利,但疫苗只有在人们服用的情况下才能发挥作用。COVID-19疫苗接种可能与疫苗接种后月经周期长度的变化有关。尽管有大量证据表明,COVID-19疫苗接种不会影响生育能力,但错误信息可能是年轻女性对疫苗犹豫不决的主要原因。随着疫苗接种计划推广到更年轻的年龄组,一些人注意到接种COVID-19疫苗后的月经变化,许多公众对这些报道感到担忧。需要进行研究,以产生可靠的数据,使医疗保健专业人员和公众了解这些潜在的副作用。据报道,月经变化与多种疫苗有关,包括那些针对非严重急性呼吸综合征冠状病毒2 (SARSCoV-2)的病原体的疫苗,因此这项工作的目的是描述SARS-CoV-2感染以及由此引起的月经周期变化。
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引用次数: 0
Determination of Caffeine and Chlorogenic Acid (CGA) in the Methanolic Extracts Coffee (C. arabica. L) To seeds and peels (Unroasted and Roasted) Cultivars Grown in Yemen by High Performance Liquid Chromatography (HPLC) 阿拉比卡咖啡甲醇提取物中咖啡因和绿原酸含量的测定。L)通过高效液相色谱法(HPLC)检测也门种植的种子和果皮(未烘烤和烘烤)
Pub Date : 2023-01-04 DOI: 10.23880/beba-16000180
Ali Sa
In this study methanolic extract of one plant namely Arabic coffee, were screened for the presence of analysis Constituents and tested for their of liquid chromatographic separation (HPLC). The quantitative HPLC analysis revealed the results showed presence of Caffeine, chlorogenic acid (CGA) is the concentration of the contents Seeds, peels (unroasted) samples is higher than their contents in the Seeds, and peels (roasted) samples. The highest concentration of Caffeine was 5,334 % in unroasted Arabica coffee peels (Udaini) in Ibb (Kafr) region, while the highest value of chlorogenic acid was 68,460% in unroasted Arabica coffee peels (Tufahi) in Ibb (Kafr). The highest concentration of Caffeine was 9,948% in unroasted Arabic coffee seeds (Udaini) in Ibb (Kafr) region, while the highest concentration of chlorogenic acid was 97,280% in unroasted Arabic coffee seeds (Udaini) in Ibb (Kafr) region. The highest concentration of Caffeine was 1,964 % in roasted Arabica coffee peels (Udaini) in Ibb (Kafr) region, while the highest value of chlorogenic acid was 26,260% in roasted Arabica coffee peels (Bura’ai.) in Sana'a (Haraz). The highest concentration of Caffeine was 2,324% in roasted Arabic coffee seeds (Udaini) in Al- Mahweet (Hufash) region, while the highest concentration of chlorogenic acid was 47,09% in roasted Arabic coffee seeds (Dawairi) in Al- Mahweet (Hufash).
本研究对一种植物阿拉伯咖啡的甲醇提取物进行了分析成分筛选,并进行了液相色谱分离试验。定量HPLC分析结果显示,咖啡因、绿原酸(CGA)的含量是种子、果皮(未烘烤)样品中含量高于其在种子和果皮(烘烤)样品中的含量。在Ibb (Kafr)地区未烘焙的阿拉比卡咖啡皮(Udaini)中咖啡因的最高浓度为5,334%,而在Ibb (Kafr)地区未烘焙的阿拉比卡咖啡皮(Tufahi)中绿原酸的最高浓度为68,460%。在Ibb (Kafr)地区未烘焙的阿拉伯咖啡种子(Udaini)中,咖啡因的最高浓度为9948%,而在Ibb (Kafr)地区未烘焙的阿拉伯咖啡种子(Udaini)中,绿原酸的最高浓度为97280%。在Ibb (Kafr)地区的烘焙阿拉比卡咖啡皮(Udaini)中,咖啡因的最高浓度为1964 %,而在萨那(Haraz)地区的烘焙阿拉比卡咖啡皮(Bura’ai)中,绿原酸的最高浓度为26,260%。Al- Mahweet (Hufash)地区烘焙的阿拉伯咖啡种子(Udaini)中咖啡因的浓度最高,为2324%,而Al- Mahweet (Hufash)地区烘焙的阿拉伯咖啡种子(Dawairi)中绿原酸的浓度最高,为47.09%。
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引用次数: 0
Therapeutic Monitoring-Guided Dosing of Factor Viii in Hemophilia A: From Pharmacodynamics and Pharmacokinetics toward Precision Therapy 血友病A的治疗监测引导因子Viii的剂量:从药效学和药代动力学到精确治疗
Pub Date : 2023-01-04 DOI: 10.23880/beba-16000185
Fortuna A
Hemophilia is a rare hypocoagulation disorder that, depending on the lacking coagulation cascade factor, has different denominations. This review focuses on Hemophilia A (HA), particularly on the FVIII concentrates that are available in clinical practice to replace the scarce levels of FVIII observed in these patients. In fact, pharmacological responses are strongly heterogenic namely due to disease evolution and FVIII concentrates pharmacokinetic profiles. Therefore, therapeutic drug monitoring (TDM) is essential to maximize FVIII effectiveness and decrease adverse event rates. We provide a critical overview of current FVIII concentrates their mechanistic and pharmacokinetic differences as well as the factors that determine those profiles. Precision dosing through therapeutic drug monitoring is expanding and is essential in populations with altered pharmacokinetics and/or pharmacodynamics. However, there is still a need for studies correlating pharmacokinetics and patient outcomes. Herein, a pharmacokinetic-based optimization of FVIII therapy was revised and in deeply explained hot it can be successfully applied in clinical practice.
血友病是一种罕见的低凝障碍,根据缺乏凝血级联因子,有不同的名称。本综述的重点是血友病A (HA),特别是在临床实践中可获得的FVIII浓缩物,以替代在这些患者中观察到的稀缺水平的FVIII。事实上,由于疾病演变和FVIII浓缩药代动力学特征,药理学反应具有很强的异质性。因此,治疗性药物监测(TDM)对于最大限度地提高FVIII有效性和降低不良事件发生率至关重要。我们提供了当前FVIII浓缩物的机制和药代动力学差异以及决定这些特征的因素的关键概述。通过治疗药物监测进行精确给药正在扩大,并且在药代动力学和/或药效学改变的人群中至关重要。然而,仍然需要研究药代动力学和患者预后之间的关系。本文对基于药代动力学的FVIII治疗优化进行了修订,并对其能否成功应用于临床进行了深入解释。
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引用次数: 0
Herceptin- A Revolutionary Tool among Personalized or Customized Medicines 赫赛汀——个性化或定制药物中的革命性工具
Pub Date : 2023-01-04 DOI: 10.23880/beba-16000192
Anju Pg
Our current medicinal practices are based on population averages. Medicines discovered in one research centre of a particular country and tested on animals and a broad population available there, are used for the treatment of worldwide population. Medicines are applying based on statistical averages gained from their randomized clinical trials. The drugs available in the world markets are only effective in 50% of the total population. Rest of them are taking medicines like placebo, means they do not produce any effects actually. It is due to the genetic differences. We all are different in every aspect. Our choices of food, our cloths, our dreams, ambitions, rituals, and cultures everything is different. But medical system prescribes drugs based on “one size fits to all”. How can that be sensible? Here comes the importance of personalized medicine. Personalized medicine or precise medicine (PM) is a newer approach of pharmacogenomics under progression. It is actually a customized kind of medicine meant for individual patients according to their genetic makeup. For that we thoroughly understand the patient details not only age and sex but in a detailed way including their genetical variations. So we can understand their drug responsiveness as early as possible. That’s why precise or personalised medicines are also called as genomic medicines. And it will also eliminate the time, cost and failures in the clinical trials which are serious issues that developing countries currently facing.
我们目前的医疗实践是基于人口平均水平。在一个特定国家的一个研究中心发现的药物,并在那里的动物和广泛人群中进行试验,用于治疗全世界的人口。药物的应用是基于随机临床试验的统计平均值。世界市场上可获得的药物仅对50%的人口有效。其余的人服用的是安慰剂之类的药物,这意味着它们实际上不会产生任何效果。这是由于基因差异。我们在各个方面都是不同的。我们对食物的选择,我们的衣服,我们的梦想,抱负,仪式和文化一切都是不同的。但是,医疗系统开药方的基础是“一刀切”。这怎么可能是明智的呢?这就是个性化医疗的重要性。个性化医疗或精确医疗(PM)是一种正在发展的药物基因组学新方法。它实际上是一种根据个体患者的基因组成定制的药物。因此,我们不仅彻底了解患者的年龄和性别,而且还详细了解他们的基因变异。这样我们就可以尽早了解他们对药物的反应。这就是为什么精确的或个性化的药物也被称为基因组药物。它还将消除临床试验的时间、成本和失败,这些都是发展中国家目前面临的严重问题。
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引用次数: 0
Level of Awareness & Attentiveness Associated to Novel Corona Virus (Covid-19) among People of Pakistan 巴基斯坦人民对新型冠状病毒(Covid-19)的认识和关注程度
Pub Date : 2023-01-04 DOI: 10.23880/beba-16000183
S. Alam
Background: Corona viruses are huge family of viruses named for the crown-like spikes on their surface. There are seven CoV viruses which will infect humans, including the “2019 Novel Corona virus” (the infection right now making features), SARS and MERS.. Symptoms include fever, breathlessness, and coughing. The illness spreads through animals and shut contact with people that have already been infected currently the virus is spreading from person to person in China as many recent cases don't seem to be related to animal markets. Method: A cross sectional investigation about the attention of corona virus (CoV), its symptoms, diagnosis and treatment was directed in several groups of individuals i.e, literate and illiterate people of Pakistan. Data was collected by means of survey based questionnaire which was prepared by the pharmacy students of Jinnah University for Women. Result: According to demographic data obtained by the cross sectional investigation about the attention of corona virus in Pakistan which was conducted among literate and illiterate people (18-25 of age).Out of which 47.9% were medical students, among these people 92.6% knew about corona virus and 97.5% people knew about its person to person transmission, and 58.8% understand its symptoms in keeping with this survey only 23.5% people knew the treatment, 76.5% people didn’t even understand the diagnosis of corona virus. Conclusion: The motivation behind this study was to assemble the information about the extent of control of corona virus with improving knowledge awareness of CoV (COVID-19) to raised inform patients about this life threatening disease in health care systems.
背景:冠状病毒是一个巨大的病毒家族,因其表面的冠状尖刺而得名。有七种冠状病毒会感染人类,包括“2019年新型冠状病毒”(目前正在形成特征的感染)、SARS和MERS。症状包括发烧、呼吸困难和咳嗽。这种疾病通过动物和与已经感染的人的密切接触传播。目前这种病毒在中国是人与人之间的传播,因为最近的许多病例似乎与动物市场无关。方法:对巴基斯坦识字和不识字人群进行冠状病毒(CoV)关注、症状、诊断和治疗的横断面调查。数据采用真纳女子大学药学专业学生自行编制的问卷调查法收集。结果:根据对巴基斯坦18-25岁文盲和识字人群冠状病毒关注度横断面调查获得的人口学资料。其中医学生占47.9%,其中92.6%的人知道冠状病毒,97.5%的人知道其人际传播,58.8%的人了解其症状,与本次调查一致,只有23.5%的人知道治疗方法,76.5%的人甚至不了解冠状病毒的诊断。结论:本研究的动机是收集有关冠状病毒控制程度的信息,提高对冠状病毒(COVID-19)的认识,以提高卫生保健系统中患者对这种威胁生命的疾病的了解。
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引用次数: 0
Updates in Gastroenterology: Acotiamide for Treatment of Functional Dyspepsia 胃肠病学最新进展:阿可替胺治疗功能性消化不良
Pub Date : 2023-01-04 DOI: 10.23880/beba-16000195
Bhalla A
Functional dyspepsia (FD) comprises of two types, the postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS). Acotiamide is a new prokinetic agent that acts by increased release of acetylcholine and is used in the treatment of FD-postprandial distress syndrome (FD-PDS). The drug initially launched in Japan is the world’s first approved treatment for FD. It exerts its activity via muscarinic receptor inhibition, which enhances acetylcholine (ACh) release, and via inhibition of acetylcholinesterase (AChE) activity in the stomach. It increases the availability of ACh on postsynaptic receptors in the enteric nervous system. The gastroprokinetic activity of acotiamide does not cause prolongation of the QT interval. Long-term studies of 48 weeks have shown a favorable clinical course with acotiamide in FD.
功能性消化不良包括餐后窘迫综合征(PDS)和胃脘痛综合征(EPS)两种类型。阿哥替胺是一种新的促动力学药物,通过增加乙酰胆碱的释放起作用,用于治疗fd -餐后窘迫综合征(FD-PDS)。该药物最初在日本上市,是世界上第一个被批准治疗FD的药物。它通过抑制毒蕈碱受体(增强乙酰胆碱(ACh)释放)和抑制胃内乙酰胆碱酯酶(AChE)活性发挥其活性。它增加了肠神经系统突触后受体上乙酰胆碱的可用性。阿可替胺的胃促动力学活性不引起QT间期的延长。48周的长期研究显示阿哥替胺治疗FD有良好的临床疗效。
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引用次数: 0
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Bioequivalence & Bioavailability International Journal
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