首页 > 最新文献

Journal of Bioequivalence & Bioavailability最新文献

英文 中文
How Pitfalls during Drug Quantitation by Mass Spectrometry May Affect the Variability of Pharmacokinetic Data during a Bioequivalence Trial 在生物等效性试验中,质谱药物定量的缺陷如何影响药代动力学数据的可变性
Pub Date : 2017-07-09 DOI: 10.4172/JBB.1000337
G. Marcelín-Jiménez
The majority of the time, during the performance of a bioequivalence trial, clinicians exercise extreme care in the selection of volunteers in order to obtain a homogeneous population, and control several sources of variation, such as diet, fasting period, hydration, and drug administration (among others), to the extent possible, to limit interand intra-individual variability and to achieve the statistical power required for the assay. In addition, monitoring staffs is charged with guaranteeing compliance with good clinical practices [1].
大多数时候,在进行生物等效性试验期间,临床医生在选择志愿者时非常小心,以获得一个均匀的人群,并尽可能控制几个变异来源,如饮食、禁食期、水合作用和药物给药(以及其他),以限制个体间和个体内部的变异,并达到试验所需的统计能力。此外,监测人员还负责保证符合临床良好规范[1]。
{"title":"How Pitfalls during Drug Quantitation by Mass Spectrometry May Affect the Variability of Pharmacokinetic Data during a Bioequivalence Trial","authors":"G. Marcelín-Jiménez","doi":"10.4172/JBB.1000337","DOIUrl":"https://doi.org/10.4172/JBB.1000337","url":null,"abstract":"The majority of the time, during the performance of a bioequivalence trial, clinicians exercise extreme care in the selection of volunteers in order to obtain a homogeneous population, and control several sources of variation, such as diet, fasting period, hydration, and drug administration (among others), to the extent possible, to limit interand intra-individual variability and to achieve the statistical power required for the assay. In addition, monitoring staffs is charged with guaranteeing compliance with good clinical practices [1].","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"1 1","pages":"430-431"},"PeriodicalIF":0.0,"publicationDate":"2017-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89454780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Effect of α-mangostin on Enhanced Transdermal Bioavailability of Gartanin via Efflux Transporters α-山竹苷通过外排转运体增强栀子苷透皮生物利用度的影响
Pub Date : 2017-06-29 DOI: 10.4172/JBB.1000344
P. Rukthong, N. Sereesongsang, T. Kulsirirat, B. Nimprayoon, K. Sathirakul
Mangosteen (Garcinia mangostana L) is a tropical evergreen tree growing in Southeast Asia and has been used as traditional medicine treatment for skin wounds and infection. The pericarp crude extract can be isolated to fifty xanthone compounds, α-, β and γ-mangostins, gartanin etc. This study aimed to characterize and compare the transdermal transport of α-mangostin and gartanin when used alone and co-administered in human epidermal keratinocyte cells, neonatal (HEKn cells). The concentrations of the compounds were determined of by LC-MS/MS. In the absorptive direction, gartanin could not be detected during the entire 8 hour. Moreover, apparent permeability coefficient in secretory direction (Papp, B-A) was significantly higher than that of absorptive direction (Papp, A-B) but not found in α-mangostin. The results showed that after incubating the HEKn cells with rotenone, Papp, A-B of gartanin was significantly increased. In contrast, Papp, A-B of α-mangostin with and without rotenone was unchanged. For the mixture of gartanin and α-mangostin, α-mangostin had the similar inhibitory effect to the uptake and secretion of gartanin to the effect of rotenone. These indicated that the effect of efflux transporter of gartanin could be inhibited by α-mangostin and the permeability of gartanin in absorptive direction was achieved with co-administration of α-mangostin at high concentration. It is postulated that alpha-mangostin may act as a natural enhancer to improve the bioavailability of gartanin. The synergistic effect of the co-existing of the compounds in the natural extract may be important for therapy.
山竹(Garcinia mangostana L)是一种生长在东南亚的热带常绿树木,被用作治疗皮肤伤口和感染的传统药物。从枸杞果皮粗提物中可分离到50个山酮类化合物,α-、β和γ-山竹苷、栀子苷等。本研究旨在表征和比较α-山竹苷和栀子苷单独使用和联合使用在人表皮角质形成细胞,新生儿(HEKn细胞)中的透皮转运。采用LC-MS/MS法测定化合物的浓度。在吸收方向上,在整个8小时内均未检测到gartanin。分泌方向(Papp, B-A)的表观通透系数显著高于吸收方向(Papp, A-B), α-山竹苷则无此现象。结果表明,鱼藤酮与HEKn细胞孵育后,gartinin的Papp、A-B均显著升高。相比之下,α-山竹苷加鱼藤酮和不加鱼藤酮后的Papp、A-B不变。在与α-山竹苷混合的情况下,α-山竹苷对栀子苷摄取和分泌的抑制作用与鱼藤酮相似。说明α-山竹苷可抑制鼠黄素外排转运体的作用,同时高浓度α-山竹苷可使鼠黄素在吸收方向上具有一定的通透性。推测α -山竹苷可能是一种天然的增强剂,可以提高gartinin的生物利用度。天然提取物中化合物共存的协同作用可能对治疗很重要。
{"title":"Effect of α-mangostin on Enhanced Transdermal Bioavailability of Gartanin via Efflux Transporters","authors":"P. Rukthong, N. Sereesongsang, T. Kulsirirat, B. Nimprayoon, K. Sathirakul","doi":"10.4172/JBB.1000344","DOIUrl":"https://doi.org/10.4172/JBB.1000344","url":null,"abstract":"Mangosteen (Garcinia mangostana L) is a tropical evergreen tree growing in Southeast Asia and has been used as traditional medicine treatment for skin wounds and infection. The pericarp crude extract can be isolated to fifty xanthone compounds, α-, β and γ-mangostins, gartanin etc. This study aimed to characterize and compare the transdermal transport of α-mangostin and gartanin when used alone and co-administered in human epidermal keratinocyte cells, neonatal (HEKn cells). The concentrations of the compounds were determined of by LC-MS/MS. In the absorptive direction, gartanin could not be detected during the entire 8 hour. Moreover, apparent permeability coefficient in secretory direction (Papp, B-A) was significantly higher than that of absorptive direction (Papp, A-B) but not found in α-mangostin. The results showed that after incubating the HEKn cells with rotenone, Papp, A-B of gartanin was significantly increased. In contrast, Papp, A-B of α-mangostin with and without rotenone was unchanged. For the mixture of gartanin and α-mangostin, α-mangostin had the similar inhibitory effect to the uptake and secretion of gartanin to the effect of rotenone. These indicated that the effect of efflux transporter of gartanin could be inhibited by α-mangostin and the permeability of gartanin in absorptive direction was achieved with co-administration of α-mangostin at high concentration. It is postulated that alpha-mangostin may act as a natural enhancer to improve the bioavailability of gartanin. The synergistic effect of the co-existing of the compounds in the natural extract may be important for therapy.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"15 10 1","pages":"455-462"},"PeriodicalIF":0.0,"publicationDate":"2017-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86661974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Improving Treatment Outcomes for Tuberculosis 改善结核病的治疗效果
Pub Date : 2017-06-22 DOI: 10.4172/JBB.1000341
Z. Zwolska
Major issues are currently associated with Tuberculosis (TB) treatment, particularly in patients infected by Multi-drug Resistant Tuberculosis/Extensively Drug Resistant Tuberculosis (mdr-TB/XDR-TB) resistant mycobacteria. A new threat recently reported in various Asian countries is totally Drug Resistant Tuberculosis (TDR). The presence of such Mycobacterium tuberculosis strains is disturbing also for the reasons they spread beyond the continent of Asia. The currently recommended tuberculosis treatment regimen is not well received by patients due to its minimum six-month, complexity, and common adverse events. The prevalence of MDR-TB and XDR-TB are inversely correlated with the quality of TB control and the proper use of second-line anti-TB drugs. Moreover, cost is extraordinary high. Since the mid-1960s only two new anti-TB drugs, bedaquiline and delamandine, have come to market; however, these drugs are not available in many regions and are limited to severely resistant cases. Currently, new derivatives such as spectinoamide are of interest in tuberculosis treatment. In vitro results and animal studies are used to aid in drug development. There is an urgent need for treatment improvement through enhancement of existing agents. Namely, individual differences in absorption and excretion of the primary anti-TB drugs, isoniazid and rifampin, require consideration. Recently, several studies attempted to evaluate the effect of anti-TB drug concentrations on treatment outcomes. Authors showed that 50-76% of the tested patients had low concentrations of INH (Isoniazid) and RMP (Rifampin). Because Therapeutic Drug Monitoring (TMD) was performed in small numbers of selected patients with comorbidities or slow treatment responses, the studies did not clearly demonstrate the effect of low drug levels on treatment outcomes. Future coordinated research is required. New molecular tests allow for research using supervised, individualized treatment of tuberculosis. In addition, effective tuberculosis outcomes require coordinated action multiple parameters for patient detection through implementation of rapid microbiological and clinical tests as well as reliable drug resistant tests of Mycobacterium tuberculosis. This leads to a break in the chain of transmission, and prevents the spread of disease in community. Education plays in important role for patients and families concerning the causes of disease and prevention methods. Additionally, medical staff should also themselves improve the level of diseases knowledge. Behaviour changes in tuberculosis infection control among medical personnel is also required. Keep in mind that one of the reasons for the relapse of tuberculosis is its disregard.
目前的主要问题与结核病(TB)治疗有关,特别是在感染耐多药结核病/广泛耐药结核病(mdr-TB/XDR-TB)耐药分枝杆菌的患者中。最近在亚洲各国报告的一个新威胁是完全耐药结核病。这种结核分枝杆菌菌株的存在也令人不安,因为它们的传播超出了亚洲大陆。目前推荐的结核病治疗方案由于其最短6个月,复杂性和常见的不良事件而不被患者所接受。耐多药结核病和广泛耐药结核病的患病率与结核病控制质量和正确使用二线抗结核药物呈负相关。此外,成本非常高。自20世纪60年代中期以来,只有两种新的抗结核病药物,贝达喹啉和德拉曼定进入市场;然而,这些药物在许多地区无法获得,并且仅限于严重耐药病例。目前,新的衍生物如spectinoamide在结核病治疗中引起了人们的兴趣。体外实验结果和动物实验用于帮助药物开发。迫切需要通过增强现有药物来改善治疗。也就是说,主要抗结核药物异烟肼和利福平的吸收和排泄的个体差异需要考虑。最近,一些研究试图评估抗结核药物浓度对治疗结果的影响。作者发现,50-76%的检测患者具有低浓度的异烟肼和利福平。由于治疗药物监测(TMD)是在少数有合并症或治疗反应缓慢的患者中进行的,因此这些研究并没有清楚地证明低药物水平对治疗结果的影响。未来需要进行协调研究。新的分子测试允许使用有监督的、个体化的结核病治疗进行研究。此外,有效的结核病治疗结果需要采取协调一致的行动,通过实施快速微生物学和临床试验以及可靠的结核分枝杆菌耐药试验来检测患者的多个参数。这导致了传播链的断裂,并防止了疾病在社区中的传播。对病人和家属进行有关疾病原因和预防方法的教育,发挥着重要作用。此外,医务人员自身也应提高疾病知识水平。还需要改变医务人员在结核病感染控制方面的行为。请记住,结核病复发的原因之一是对它的漠视。
{"title":"Improving Treatment Outcomes for Tuberculosis","authors":"Z. Zwolska","doi":"10.4172/JBB.1000341","DOIUrl":"https://doi.org/10.4172/JBB.1000341","url":null,"abstract":"Major issues are currently associated with Tuberculosis (TB) treatment, particularly in patients infected by Multi-drug Resistant Tuberculosis/Extensively Drug Resistant Tuberculosis (mdr-TB/XDR-TB) resistant mycobacteria. A new threat recently reported in various Asian countries is totally Drug Resistant Tuberculosis (TDR). The presence of such Mycobacterium tuberculosis strains is disturbing also for the reasons they spread beyond the continent of Asia. \u0000The currently recommended tuberculosis treatment regimen is not well received by patients due to its minimum six-month, complexity, and common adverse events. The prevalence of MDR-TB and XDR-TB are inversely correlated with the quality of TB control and the proper use of second-line anti-TB drugs. Moreover, cost is extraordinary high. Since the mid-1960s only two new anti-TB drugs, bedaquiline and delamandine, have come to market; however, these drugs are not available in many regions and are limited to severely resistant cases. Currently, new derivatives such as spectinoamide are of interest in tuberculosis treatment. In vitro results and animal studies are used to aid in drug development. \u0000There is an urgent need for treatment improvement through enhancement of existing agents. Namely, individual differences in absorption and excretion of the primary anti-TB drugs, isoniazid and rifampin, require consideration. Recently, several studies attempted to evaluate the effect of anti-TB drug concentrations on treatment outcomes. Authors showed that 50-76% of the tested patients had low concentrations of INH (Isoniazid) and RMP (Rifampin). Because Therapeutic Drug Monitoring (TMD) was performed in small numbers of selected patients with comorbidities or slow treatment responses, the studies did not clearly demonstrate the effect of low drug levels on treatment outcomes. Future coordinated research is required. \u0000New molecular tests allow for research using supervised, individualized treatment of tuberculosis. In addition, effective tuberculosis outcomes require coordinated action multiple parameters for patient detection through implementation of rapid microbiological and clinical tests as well as reliable drug resistant tests of Mycobacterium tuberculosis. This leads to a break in the chain of transmission, and prevents the spread of disease in community. Education plays in important role for patients and families concerning the causes of disease and prevention methods. Additionally, medical staff should also themselves improve the level of diseases knowledge. Behaviour changes in tuberculosis infection control among medical personnel is also required. Keep in mind that one of the reasons for the relapse of tuberculosis is its disregard.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"270 1","pages":"442-446"},"PeriodicalIF":0.0,"publicationDate":"2017-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74939318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
An Overview on Stability of Extemporaneously Prepared Pharmaceutical Suspension 临时制备药物混悬液稳定性研究综述
Pub Date : 2017-06-19 DOI: 10.4172/jbb.1000343
S. Naveed, F. Akhtar, S. Khan
Aim: The aim of this study was to write review on stability studies of extemporaneous preparations. Materials and methods: Different methods are used for checking stability studies, depending on the nature of the preparations, like visual inspection, pH checking, different temperature storage, and HPLC. Results: It was found that the stability concern with the pharmaceutical suspensions includes the variation in both physical and chemical properties. Therefore, it is most important that formulator must ensure the efficacy of the formulation throughout the shelf life period. In this review article, method used for stability checking is valid and up to mark, so patient can use these extemporaneous preparations according to recommended period of time. Conclusion: We can conclude of our Stress studies that these suspensions cannot be stored over long period of time (average 90-120 days); but they are stable below 120 days (depending on the preparation) so we can have used these preparations because there is no stability issue if used in within recommended time-period, undeniably extemporaneously prepared suspensions can be a helpful for pediatric, geriatric and unconscious patients in drug dosing.
目的:对即食制剂的稳定性研究进行综述。材料和方法:根据制剂的性质,检查稳定性研究使用不同的方法,如目视检查、pH检查、不同温度储存和HPLC。结果:药物混悬液的稳定性问题包括物理性质和化学性质的变化。因此,最重要的是配方师必须确保配方在整个保质期内的功效。本文所采用的稳定性检查方法是有效的,达到了标准,因此患者可以根据推荐的时间使用这些临时制剂。结论:我们的应力研究可以得出结论,这些悬浮液不能长时间储存(平均90-120天);但它们在120天以下是稳定的(取决于制剂),所以我们可以使用这些制剂,因为如果在推荐的时间内使用,没有稳定性问题,不可否认,临时制备的混悬液可以帮助儿童,老年人和无意识的患者给药。
{"title":"An Overview on Stability of Extemporaneously Prepared Pharmaceutical Suspension","authors":"S. Naveed, F. Akhtar, S. Khan","doi":"10.4172/jbb.1000343","DOIUrl":"https://doi.org/10.4172/jbb.1000343","url":null,"abstract":"Aim: The aim of this study was to write review on stability studies of extemporaneous preparations. \u0000Materials and methods: Different methods are used for checking stability studies, depending on the nature of the preparations, like visual inspection, pH checking, different temperature storage, and HPLC. \u0000Results: It was found that the stability concern with the pharmaceutical suspensions includes the variation in both physical and chemical properties. Therefore, it is most important that formulator must ensure the efficacy of the formulation throughout the shelf life period. In this review article, method used for stability checking is valid and up to mark, so patient can use these extemporaneous preparations according to recommended period of time. \u0000Conclusion: We can conclude of our Stress studies that these suspensions cannot be stored over long period of time (average 90-120 days); but they are stable below 120 days (depending on the preparation) so we can have used these preparations because there is no stability issue if used in within recommended time-period, undeniably extemporaneously prepared suspensions can be a helpful for pediatric, geriatric and unconscious patients in drug dosing.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"70 1","pages":"452-454"},"PeriodicalIF":0.0,"publicationDate":"2017-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72729729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Alpha-D-Galactosidase does not Interfere with Trimebutine OralPharmacokinetics in Mexican Healthy Volunteers α - d -半乳糖苷酶不干扰曲美布汀在墨西哥健康志愿者的口服药代动力学
Pub Date : 2017-06-16 DOI: 10.4172/JBB.1000342
Penaloza Becerra CA, Ortega Escamilla E, Vasquez Vasquez JE, Marcelin Jimenez G, P Angeles Moreno AC, Garcia Gonzalez A, Laguna Leyte JS, Koretzky Sg, Batista Dieguez D, Lopez Sanchez P
Gas production is a common symptom in bowel affections. There are different formulations to improve general symptoms, including motility regulators, such as trimebutine, and surfactants, such as simethicone, or both. These approaches, however, do not affect gas production. Methane, hydrogen, carbon dioxide, and water are generated in the intestines due to action of bacterial flora on non-digestible carbohydrates from the diet. The unfolding of these carbohydrates by specific enzymes promises greater improvement of symptomatology. Alpha-D-Galactosidase degrades these carbohydrates from diet. It is not known whether the addition of this enzyme modifies trimebutine pharmacokinetics. Thus, our aim was to assess whether the addition of Alpha-D-Galactosidase to a commercial formulation alters trimebutine oral pharmacokinetics. We conducted a controlled, cross-over, randomized, simpleblind, two-period, two-treatment, and two-sequence clinical trial on 30 healthy Mexican volunteers, receiving a single dose of reference product and test product. Pharmacokinetics and safety of usage were obtained. We measured N-desmethyl-trimebutine, the major metabolite of trimebutine. We showed that addition of galactosidase does not modify any pharmacokinetic parameter significantly. Safety of the subjects was not affected. We conclude that alpha-D-Galactosidase does not modify oral pharmacokinetics of trimebutine, rendering this approach suitable for commercial use in indicated bowel affections.
产气是肠道疾病的常见症状。有不同的配方可以改善一般症状,包括运动调节剂,如曲美布汀,和表面活性剂,如西甲硅氧烷,或两者兼而有之。然而,这些方法并不影响天然气产量。肠道内的甲烷、氢、二氧化碳和水是由于细菌群对饮食中不可消化的碳水化合物的作用而产生的。通过特定的酶来分解这些碳水化合物有望更大程度地改善症状。- d -半乳糖苷酶从饮食中降解这些碳水化合物。目前尚不清楚这种酶的加入是否会改变曲美布汀的药代动力学。因此,我们的目的是评估在商业配方中添加α - d -半乳糖苷酶是否会改变曲美布汀的口服药代动力学。我们对30名健康的墨西哥志愿者进行了一项对照、交叉、随机、单盲、两期、两治疗、两顺序的临床试验,接受单剂量的参考产品和测试产品。进行了药代动力学和安全性分析。我们测量了曲美布汀的主要代谢物n -去甲基曲美布汀。我们发现添加半乳糖苷酶不会显著改变任何药代动力学参数。受试者的安全没有受到影响。我们得出结论,α - d -半乳糖苷酶不会改变曲美布汀的口服药代动力学,因此这种方法适合用于肠道疾病的商业应用。
{"title":"Alpha-D-Galactosidase does not Interfere with Trimebutine OralPharmacokinetics in Mexican Healthy Volunteers","authors":"Penaloza Becerra CA, Ortega Escamilla E, Vasquez Vasquez JE, Marcelin Jimenez G, P Angeles Moreno AC, Garcia Gonzalez A, Laguna Leyte JS, Koretzky Sg, Batista Dieguez D, Lopez Sanchez P","doi":"10.4172/JBB.1000342","DOIUrl":"https://doi.org/10.4172/JBB.1000342","url":null,"abstract":"Gas production is a common symptom in bowel affections. There are different formulations to improve general symptoms, including motility regulators, such as trimebutine, and surfactants, such as simethicone, or both. These approaches, however, do not affect gas production. Methane, hydrogen, carbon dioxide, and water are generated in the intestines due to action of bacterial flora on non-digestible carbohydrates from the diet. The unfolding of these carbohydrates by specific enzymes promises greater improvement of symptomatology. Alpha-D-Galactosidase degrades these carbohydrates from diet. It is not known whether the addition of this enzyme modifies trimebutine pharmacokinetics. Thus, our aim was to assess whether the addition of Alpha-D-Galactosidase to a commercial formulation alters trimebutine oral pharmacokinetics. We conducted a controlled, cross-over, randomized, simpleblind, two-period, two-treatment, and two-sequence clinical trial on 30 healthy Mexican volunteers, receiving a single dose of reference product and test product. Pharmacokinetics and safety of usage were obtained. We measured N-desmethyl-trimebutine, the major metabolite of trimebutine. We showed that addition of galactosidase does not modify any pharmacokinetic parameter significantly. Safety of the subjects was not affected. We conclude that alpha-D-Galactosidase does not modify oral pharmacokinetics of trimebutine, rendering this approach suitable for commercial use in indicated bowel affections.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"17 1","pages":"447-451"},"PeriodicalIF":0.0,"publicationDate":"2017-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83217855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Decision-Theoretical Perspective on Bioequivalence 生物等效性的决策理论视角
Pub Date : 2017-06-12 DOI: 10.4172/JBB.1000339
Long Nt
Bioequivalence is a term used for the property of two treatments, formulations, or medical products (henceforth treatments) that their effects in a specified population are identical, or that the treatments can be interchanged without any differential therapeutic impact. In most contexts, ‘identical’ is qualified by ‘for all intents and purposes’, is acknowledged to mean ‘similar’, or is meant to be interpreted as such. In established approaches, providing evidence of bioequivalence amounts to rejecting the hypothesis that the difference of the average effects of the two treatments, Δ, is distant from zero-that the two-average treatment effects are dissimilar. A study to provide such evidence should start by defining the borderline between similar and dissimilar. It comprises a positive and a negative value, Δ+ > 0 and Δ< 0, or the interval they delimit, which contains zero. If we knew that the treatment effect is within this interval we would declare bioequivalence (B), and would declare dissimilarity (D) otherwise. Setting both δ and δ to zero corresponds to a dichotomy that is false because with such a degenerate borderline it would be safe to conclude that bioequivalence is absent. After all, there are uncountably many alternatives to the exact zero, and uncountably many of them are arbitrarily close to zero [1].
生物等效性是指两种治疗方法、制剂或医疗产品(以下简称治疗)在特定人群中的效果相同,或者两种治疗方法可以互换而不会产生任何不同的治疗效果的特性。在大多数情况下,“相同”被限定为“出于所有意图和目的”,被认为是“相似”的意思,或者被解释为“相似”。在已建立的方法中,提供生物等效性的证据相当于拒绝两种治疗的平均效果的差异(Δ)远离零的假设,即两种平均治疗效果是不同的。提供这类证据的研究应该从定义相似和不同之间的界限开始。它包含一个正值和一个负值,Δ+ > 0和Δ< 0,或者它们所分隔的区间,其中包含0。如果我们知道治疗效果在这个区间内,我们将声明生物等效性(B),否则将声明差异性(D)。将δ和δ设为零对应于错误的二分法,因为有了这样一个退化的边界,可以安全地得出生物等效性不存在的结论。毕竟,精确的零有无数种选择,其中有无数种任意接近零。
{"title":"A Decision-Theoretical Perspective on Bioequivalence","authors":"Long Nt","doi":"10.4172/JBB.1000339","DOIUrl":"https://doi.org/10.4172/JBB.1000339","url":null,"abstract":"Bioequivalence is a term used for the property of two treatments, formulations, or medical products (henceforth treatments) that their effects in a specified population are identical, or that the treatments can be interchanged without any differential therapeutic impact. In most contexts, ‘identical’ is qualified by ‘for all intents and purposes’, is acknowledged to mean ‘similar’, or is meant to be interpreted as such. In established approaches, providing evidence of bioequivalence amounts to rejecting the hypothesis that the difference of the average effects of the two treatments, Δ, is distant from zero-that the two-average treatment effects are dissimilar. A study to provide such evidence should start by defining the borderline between similar and dissimilar. It comprises a positive and a negative value, Δ+ > 0 and Δ< 0, or the interval they delimit, which contains zero. If we knew that the treatment effect is within this interval we would declare bioequivalence (B), and would declare dissimilarity (D) otherwise. Setting both δ and δ to zero corresponds to a dichotomy that is false because with such a degenerate borderline it would be safe to conclude that bioequivalence is absent. After all, there are uncountably many alternatives to the exact zero, and uncountably many of them are arbitrarily close to zero [1].","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"9 1","pages":"437-438"},"PeriodicalIF":0.0,"publicationDate":"2017-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78547062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Enhanced Bioavailability and Anticancer Activity of Vitamin Analogs 维生素类似物提高生物利用度和抗癌活性
Pub Date : 2017-06-12 DOI: 10.4172/JBB.1000340
Kakullamarri Pr, R. Kln
There is increased evidence to show that dietary supplementation of vitamins contributes to cancer prevention and also therapy. This paper explains the anticancer activity of few vitamins and the necessity of preparing their analogs to enhance their bioavailability. While the vitamin supplementation is needed in various health disorders, over supplementation of the same may not be effective due to failure to reach over maximal concentrations in the body. Vitamin mediated anticancer activities include cell cycle progression inhibition, targeting cell survival, inducing autophagy or apoptosis, inhibiting hypoxia, eradication of oxygen free radicals and immune modulation. As the in vitro data seems sufficient to support vitamin biological effects, advanced research is needed to support their in vivo activity and long-term treatment.
越来越多的证据表明,膳食补充维生素有助于癌症的预防和治疗。本文阐述了几种维生素的抗癌活性及其制备类似物以提高其生物利用度的必要性。虽然各种健康疾病都需要补充维生素,但由于未能达到体内最大浓度,过量补充维生素可能不会有效。维生素介导的抗癌活性包括抑制细胞周期进程,靶向细胞存活,诱导自噬或凋亡,抑制缺氧,清除氧自由基和免疫调节。由于体外数据似乎足以支持维生素的生物学效应,需要进一步的研究来支持其体内活性和长期治疗。
{"title":"Enhanced Bioavailability and Anticancer Activity of Vitamin Analogs","authors":"Kakullamarri Pr, R. Kln","doi":"10.4172/JBB.1000340","DOIUrl":"https://doi.org/10.4172/JBB.1000340","url":null,"abstract":"There is increased evidence to show that dietary supplementation of vitamins contributes to cancer prevention and also therapy. This paper explains the anticancer activity of few vitamins and the necessity of preparing their analogs to enhance their bioavailability. While the vitamin supplementation is needed in various health disorders, over supplementation of the same may not be effective due to failure to reach over maximal concentrations in the body. Vitamin mediated anticancer activities include cell cycle progression inhibition, targeting cell survival, inducing autophagy or apoptosis, inhibiting hypoxia, eradication of oxygen free radicals and immune modulation. As the in vitro data seems sufficient to support vitamin biological effects, advanced research is needed to support their in vivo activity and long-term treatment.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"31 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84312209","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ventilator-Associated Pneumonia (VAP): Clinical Strategies, TreatmentChallenges and Economic Concerns 呼吸机相关性肺炎(VAP):临床策略、治疗挑战和经济问题
Pub Date : 2017-06-08 DOI: 10.4172/JBB.1000338
S. Zubair, H. Ali, F. Zafar, A. E. Beg, Ali Akbar Sial, S. Naveed, S. Saleem, A. Tariq
The clinical and economic features of Ventilator-Associated Pneumonia (VAP) are quite unclear, with an extensive array of values and contradictory results. The real challenge in this connection is to present the real estimate of the clinical and associated economic consequences of VAP. In developing countries like Pakistan, it is important to formulate an optimal institutional antimicrobial policy that can be used as a guide for empirical/prophylactic and specific therapies of antibiotics in VAP with more rational approach to lessen the rates of mortality and morbidity, decline the length of treatment and hospitalization and the significant impact in prevention of development of multidrug resistant strains and cost reduction.
呼吸机相关性肺炎(VAP)的临床和经济特征尚不清楚,具有广泛的价值和相互矛盾的结果。在这方面的真正挑战是提出VAP临床和相关经济后果的真实估计。在巴基斯坦等发展中国家,重要的是制定最佳的制度性抗微生物政策,可作为VAP经验/预防性和特异性抗生素治疗的指南,以更合理的方式降低死亡率和发病率,缩短治疗和住院时间,并在预防多药耐药菌株的发展和降低成本方面产生重大影响。
{"title":"Ventilator-Associated Pneumonia (VAP): Clinical Strategies, TreatmentChallenges and Economic Concerns","authors":"S. Zubair, H. Ali, F. Zafar, A. E. Beg, Ali Akbar Sial, S. Naveed, S. Saleem, A. Tariq","doi":"10.4172/JBB.1000338","DOIUrl":"https://doi.org/10.4172/JBB.1000338","url":null,"abstract":"The clinical and economic features of Ventilator-Associated Pneumonia (VAP) are quite unclear, with an extensive array of values and contradictory results. The real challenge in this connection is to present the real estimate of the clinical and associated economic consequences of VAP. In developing countries like Pakistan, it is important to formulate an optimal institutional antimicrobial policy that can be used as a guide for empirical/prophylactic and specific therapies of antibiotics in VAP with more rational approach to lessen the rates of mortality and morbidity, decline the length of treatment and hospitalization and the significant impact in prevention of development of multidrug resistant strains and cost reduction.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"94 1","pages":"432-436"},"PeriodicalIF":0.0,"publicationDate":"2017-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77010249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
A novel in vitro method to analyse the performance of subcutaneous formulations 一种新的体外方法来分析皮下制剂的性能
Pub Date : 2017-06-01 DOI: 10.4172/0975-0851-C1-030
Jesus B Alonso
{"title":"A novel in vitro method to analyse the performance of subcutaneous formulations","authors":"Jesus B Alonso","doi":"10.4172/0975-0851-C1-030","DOIUrl":"https://doi.org/10.4172/0975-0851-C1-030","url":null,"abstract":"","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76347153","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 47
The Accepted “Clinical Interaction Model”: A Special Case of Reality 公认的“临床相互作用模式”:现实的特例
Pub Date : 2017-05-26 DOI: 10.4172/JBB.1000335
J. Kristiansen, S. Fey
Pharmacology has focussed on the effects of compounds on tissues and organs with a view to promoting the well-being of a patient. This has been a special case of ‘reality’. With the dual realisation that these compounds can also have effects on microorganisms living in and on the patient and that these microorganisms play a vital role in maintaining the health of the patient it is essential that we modify our perspective to include the host, the microorganisms and compounds that affect either into a general theory for pharmacology.
药理学侧重于化合物对组织和器官的影响,以期促进患者的健康。这是“现实”的一个特例。有了双重认识,这些化合物也可以对生活在病人体内和身上的微生物产生影响,这些微生物在维持病人健康方面起着至关重要的作用,我们有必要修改我们的观点,将宿主、微生物和影响其中任何一种的化合物纳入药理学的一般理论。
{"title":"The Accepted “Clinical Interaction Model”: A Special Case of Reality","authors":"J. Kristiansen, S. Fey","doi":"10.4172/JBB.1000335","DOIUrl":"https://doi.org/10.4172/JBB.1000335","url":null,"abstract":"Pharmacology has focussed on the effects of compounds on tissues and organs with a view to promoting the well-being of a patient. This has been a special case of ‘reality’. With the dual realisation that these compounds can also have effects on microorganisms living in and on the patient and that these microorganisms play a vital role in maintaining the health of the patient it is essential that we modify our perspective to include the host, the microorganisms and compounds that affect either into a general theory for pharmacology.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"5 1","pages":"418-423"},"PeriodicalIF":0.0,"publicationDate":"2017-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88513680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
期刊
Journal of Bioequivalence & Bioavailability
全部 Acc. Chem. Res. ACS Applied Bio Materials ACS Appl. Electron. Mater. ACS Appl. Energy Mater. ACS Appl. Mater. Interfaces ACS Appl. Nano Mater. ACS Appl. Polym. Mater. ACS BIOMATER-SCI ENG ACS Catal. ACS Cent. Sci. ACS Chem. Biol. ACS Chemical Health & Safety ACS Chem. Neurosci. ACS Comb. Sci. ACS Earth Space Chem. ACS Energy Lett. ACS Infect. Dis. ACS Macro Lett. ACS Mater. Lett. ACS Med. Chem. Lett. ACS Nano ACS Omega ACS Photonics ACS Sens. ACS Sustainable Chem. Eng. ACS Synth. Biol. Anal. Chem. BIOCHEMISTRY-US Bioconjugate Chem. BIOMACROMOLECULES Chem. Res. Toxicol. Chem. Rev. Chem. Mater. CRYST GROWTH DES ENERG FUEL Environ. Sci. Technol. Environ. Sci. Technol. Lett. Eur. J. Inorg. Chem. IND ENG CHEM RES Inorg. Chem. J. Agric. Food. Chem. J. Chem. Eng. Data J. Chem. Educ. J. Chem. Inf. Model. J. Chem. Theory Comput. J. Med. Chem. J. Nat. Prod. J PROTEOME RES J. Am. Chem. Soc. LANGMUIR MACROMOLECULES Mol. Pharmaceutics Nano Lett. Org. Lett. ORG PROCESS RES DEV ORGANOMETALLICS J. Org. Chem. J. Phys. Chem. J. Phys. Chem. A J. Phys. Chem. B J. Phys. Chem. C J. Phys. Chem. Lett. Analyst Anal. Methods Biomater. Sci. Catal. Sci. Technol. Chem. Commun. Chem. Soc. Rev. CHEM EDUC RES PRACT CRYSTENGCOMM Dalton Trans. Energy Environ. Sci. ENVIRON SCI-NANO ENVIRON SCI-PROC IMP ENVIRON SCI-WAT RES Faraday Discuss. Food Funct. Green Chem. Inorg. Chem. Front. Integr. Biol. J. Anal. At. Spectrom. J. Mater. Chem. A J. Mater. Chem. B J. Mater. Chem. C Lab Chip Mater. Chem. Front. Mater. Horiz. MEDCHEMCOMM Metallomics Mol. Biosyst. Mol. Syst. Des. Eng. Nanoscale Nanoscale Horiz. Nat. Prod. Rep. New J. Chem. Org. Biomol. Chem. Org. Chem. Front. PHOTOCH PHOTOBIO SCI PCCP Polym. Chem.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1