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Journal of Bioequivalence & Bioavailability最新文献

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Effect of Food through Drug Delivery System 食品通过药物输送系统的效果
Pub Date : 2021-01-01 DOI: 10.35248/0975-0851.21.13.426
Rami Vivek
Gastro retentive medication conveyance frameworks have been investigated for controlling the arrival of the medications by oral organization These frameworks are in touch with the gastric substance for longer time and subsequently, "Food" is required to meddle with the pace of assimilation from these frameworks. This article centers around different food sources related elements liable for influencing assimilation from the GRDDS kind of novel framework.
胃保留性药物输送框架已被研究用于控制口服组织药物的到达,这些框架与胃物质接触的时间更长,随后,“食物”需要干预这些框架的同化速度。本文从GRDDS这种新框架出发,围绕不同食物来源影响同化的相关因素展开研究。
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引用次数: 0
Bioavailability and bioequivalence of allopurinol in two tablet formulations 别嘌呤醇两种片剂制剂的生物利用度和生物等效性
Pub Date : 2021-01-01 DOI: 10.35248/0975-0851.21.S2.001
Santif Gen
Allopurinol is a compelling inhibitor of the catalyst xanthine oxidase, use for diminishing the blood centralizations of urate and, in this manner, to diminish the amount of rehashed attacks of gout. Allopurinol is used to oxipurinol, and hypouricaemic adequacy of allopurinol is expected in enormous part to this metabolite.
别嘌呤醇是催化剂黄嘌呤氧化酶的一种强有力的抑制剂,用于减少血液中尿酸的集中,并以这种方式减少痛风发作的次数。别嘌呤醇被用于氧化嘌呤醇,而别嘌呤醇的低血充分性在很大程度上是由这种代谢物引起的。
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引用次数: 0
Editorial note on Herbal Plants 《草本植物》社论注释
Pub Date : 2021-01-01 DOI: 10.35248/0975-0851.21.13.E429
Chakri Ram
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引用次数: 0
Deviation Range to Address Genuine Bioavailability 解决真正生物利用度的偏差范围
Pub Date : 2021-01-01 DOI: 10.35248/0975-0851.21.S1.E002
D. Sebastian
In pharmacology, bioavailability (BA or F) is a subcategory of retention and is the part (%) of a controlled medication that arrives at the foundational flow.
在药理学中,生物利用度(BA或F)是保留率的一个子类,是受控药物到达基础流的部分(%)。
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引用次数: 0
Pharmacokinetics and Condensed New Drug Application 药代动力学与浓缩新药应用
Pub Date : 2021-01-01 DOI: 10.35248/0975-0851.21.S1.E004
C. Dobrea
Pharmacokinetics (from Ancient Greek pharmakon "drug" and kinetikos "moving, placing moving"; see synthetic energy), now and then curtailed as PK, is a part of pharmacology devoted to decide the destiny of substances directed to a living creature.
药代动力学(源自古希腊语pharmakon“药物”和kinetikos“移动,放置移动”;(参见合成能量),有时简称为PK,是药理学的一部分,致力于决定直接作用于生物的物质的命运。
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引用次数: 0
Vitamin B12 for Cognitive Functions in Elderly 维生素B12对老年人认知功能的影响
Pub Date : 2021-01-01 DOI: 10.35248/0975-0851.21.S3.003
R. Thomas
Maturing is frequently joined by a decrease in psychological and engine capacities and in emotional wellness. Albeit thought about piece of maturing, these conditions may have nutrient B12 inadequacy as a hidden instrument. Exploration on the impact of nutrient B12 on cerebrum wellbeing has dwindled down as numerous investigations revealed negative relationship among vB12D and mind wellbeing. Nonetheless, numerous patients show wide or minor side effects that leave vB12D undocumented.
成熟往往伴随着心理和动力能力的下降以及情感健康的下降。虽然考虑到成熟的部分,这些条件可能有营养B12不足作为一个隐藏的工具。关于维生素B12对大脑健康影响的研究越来越少,因为大量研究表明维生素B12与大脑健康之间存在负相关关系。尽管如此,许多患者表现出广泛或轻微的副作用,这使得vB12D没有记录。
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引用次数: 0
Effect of Fatty Acids on Bioavailability 脂肪酸对生物利用度的影响
Pub Date : 2021-01-01 DOI: 10.35248/0975-0851.21.13.427
Erdal Dani
A few examinations with formed unsaturated fats have been completed by our gathering. They have been proposed by the creators of this for over 30 years. This specific exploration with formed unsaturated fats was begun and grown over six years prior. The examination's point has been to explain their parts of wellbeing, bioavailability, and usefulness. Formed unsaturated fats essentially begin from the linoleic (CLA) and the linolenic (CLNA) unsaturated fats, through substance, enzymatic and metabolic cycles. With respect to their primary structures, they can be described when they are contrasted with the unsaturated fats that led to them, where the change from unconjugated twofold securities to formation happens.
我们的聚会已经完成了一些关于形成的不饱和脂肪的检查。30多年来,它的创造者一直在提出这个想法。这种对形成的不饱和脂肪的具体探索是在六年前开始和发展的。这项研究的重点是解释它们在健康、生物利用度和有用性方面的作用。形成的不饱和脂肪基本上是从亚油酸(CLA)和亚麻酸(CLNA)不饱和脂肪开始,经过物质、酶和代谢循环。关于它们的初级结构,当它们与导致它们的不饱和脂肪相比时,它们可以被描述,不饱和脂肪是从非共轭的双重证券转变为形成的。
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引用次数: 0
Short Note on Drug Development 关于药物开发的简述
Pub Date : 2021-01-01 DOI: 10.35248/0975-0851.21.S2.E002
L. Roche
Bioavailability is alluded to as the degree and rate to which the dynamic medication fixing or dynamic moiety from the medication item is ingested and opens up at the site of medication activity. The general bioavailability as far as the rate and degree of medication ingestion is viewed as prescient of clinical results. In 1984, the United States Food and Drug Administration (FDA) was approved to endorse conventional medication items under the Drug Price Competition and Patent Term Restoration Act dependent on proof of normal bioequivalence in drug assimilation through the direct of bioavailability and bioequivalence considers.
生物利用度指的是动态药物固定物或药物项目的动态部分被摄入并在药物活性部位打开的程度和速率。一般的生物利用度,就药物摄取的速度和程度而言,被视为临床结果的先见之明。1984年,美国食品和药物管理局(FDA)根据《药品价格竞争和专利期限恢复法案》,通过直接考虑生物利用度和生物等效性,批准常规药物项目依赖于药物同化中的正常生物等效性证明。
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引用次数: 0
Bioequivalence Studies for Generic Drug Development 仿制药开发的生物等效性研究
Pub Date : 2020-01-01 DOI: 10.35248/0975-0851.20.12.410
F. Sorgel
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引用次数: 0
A Full Replicate in vivo Bioequivalence Study of Two Idelalisib 150 mg Tablets in Fasted Healthy Adult Human Subjects 两种150mg Idelalisib片剂在空腹健康成人体内的生物等效性研究
Pub Date : 2020-01-01 DOI: 10.35248/0975-0851.20.12.391
A. Arumugam, A. Mani, J. Chirinos
Background: Idelalisib, a PI3K small molecule inhibitor, specifically blocks the phosphatidylinositol-4, 5-bisphosphate 3-kinase catalytic subunit delta isoform (PI3Kδ). This is a potent drug which is specifically targeted for relapsed chronic lymphocytic leukemia (CLL). Methods and Findings: A full replicate bioequivalence study of two Idelalisib 150 mg tablets was conducted in 56 healthy adult human subjects under fasting conditions with a washout period of 10 days in between doses. Blood samples were collected up to 72 hours post-dose for measurement of pharmacokinetic parameters in all periods to quantify Idelalisib in human plasma using a validated LC-MS/MS method. Bioequivalence between both the products was established by calculating 90% confidence intervals (90% CI) for the ratio of Cmax and AUC0-t values for the test and reference products. The 90% confidence intervals found for the relation of Test/Reference were Cmax 92.23% - 106.06% and AUC0-t 96.62% - 105.27%. Conclusion: According to FDA's guidelines for Bioequivalence research and based on the ANOVA results obtained, it can be concluded that Idelalisib 150 mg tablets of Abbott Laboratories de Colombia is bioequivalent to Zydelig (Idelalisib) 150 mg tablets of Gilead Sciences Ltd under fasting conditions.
背景:Idelalisib是一种PI3K小分子抑制剂,可特异性阻断磷脂酰肌醇- 4,5 -二磷酸3-激酶催化亚基δ异构体(PI3Kδ)。这是一种有效的药物,专门针对复发性慢性淋巴细胞白血病(CLL)。方法和发现:在56名健康成人受试者中,在禁食条件下进行了两种150mg Idelalisib片的全重复生物等效性研究,两剂之间的洗脱期为10天。在给药后72小时内采集血样,测量所有时期的药代动力学参数,使用经过验证的LC-MS/MS方法定量人血浆中的Idelalisib。通过计算试验品和参比品Cmax和AUC0-t比值的90%置信区间(90% CI),确定两种产品之间的生物等效性。检验/参考关系的90%置信区间为Cmax 92.23% ~ 106.06%, AUC0-t 96.62% ~ 105.27%。结论:根据FDA的生物等效性研究指南,基于获得的方差分析结果,可以得出结论,在禁食条件下,雅培哥伦比亚公司的Idelalisib 150mg片与吉利德科学公司的Zydelig (Idelalisib) 150mg片具有生物等效性。
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引用次数: 3
期刊
Journal of Bioequivalence & Bioavailability
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