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Evaluation of an immunoassay for the antithyroglobulin and antithyroperoxidase measuring 抗甲状腺球蛋白和抗过氧化物酶免疫测定法的评估
Q Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-30 DOI: 10.53519/analesranf.2023.89.02.05
J. L. Martı́n-Calderón
Introduction: The measuring of antibodies against thyroglobulin (ATG) and thyroperoxydase (ATPO) is useful for identifying patients with autoimmunethyroiditis. This study tries to assess an electrochemiluminescent immunoassay for ATG and ATPO, evaluating imprecision, linearity, analytic sensitivity, carry-over and the influence of endogenous interferents. Material and methods: Imprecision was assessed using three pools with different analytes concentrations, performing within run and between run 20 times. Fort the linearity study a sample containing high analyte concentration and a solvent devoid of analyte were combined, obtaining intermediates concentrations, which were analyzed by triplicate. The limit of detection was calculated analyzing 20 times a sample devoid of analyte. Carry-over was evaluated analyzing a sample with a high antibody concentration followed by other one containing low antibody concentration. The interference study was carried-out adding hemolyzed, Intralipid 30% and bilirubin into sera pool. Results: Total imprecision obtained (%) were 26.63, 9.53, and 14.9 for ATG and 21.19, 14.82, and 5.77 for ATPO. Linearity was defined for the following regression equations: Y=6.61+1.01X (ATG) and, Y=16.37+0.97X (ATPO). The limit of detection was 17.17 for ATG and 5 for ATPO. Carry-over was not significant. Hemolysis caused significant interference in both assays. Conclusions: Imprecision obtained were similar to the manufacturer declared ones. Analytic sensibility complies the manufacturer’s specifications. The behavior of both assays was linear and significant carry-over was not found. Hemolysis interferes in both assays.
简介测量甲状腺球蛋白(ATG)和甲状腺过氧化物酶(ATPO)抗体有助于鉴别自身免疫性甲状腺炎患者。本研究试图评估 ATG 和 ATPO 的电化学发光免疫分析法,评价其不精确度、线性度、分析灵敏度、携带率和内源性干扰物的影响。材料和方法使用三个具有不同分析物浓度的样品池对不精确度进行评估,在运行内和运行间各进行 20 次。在线性研究中,将含有高浓度分析物的样品与不含分析物的溶剂混合,得到中间体浓度,并进行一式三份的分析。在对不含分析物的样品进行 20 次分析后,计算出了检测限。在分析高浓度抗体样品后,再分析低浓度抗体样品,以评估抗体携带率。在血清池中加入溶血、30% 的内脂和胆红素进行干扰研究。结果ATG 的总不精确度(%)分别为 26.63、9.53 和 14.9,ATPO 的总不精确度(%)分别为 21.19、14.82 和 5.77。线性回归方程如下Y=6.61+1.01X(ATG)和,Y=16.37+0.97X(ATPO)。ATG 的检测限为 17.17,ATPO 的检测限为 5。迁移不明显。溶血对两种检测方法都有明显干扰。结论:所获得的不精密度与生产商声明的不精密度相似。分析灵敏度符合制造商的规格要求。两种测定的行为均呈线性,未发现明显的携带现象。溶血对两种测定都有干扰。
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引用次数: 0
Influence of chronic statin use on the hydration status of older people 长期服用他汀类药物对老年人水合状态的影响
Q Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-30 DOI: 10.53519/analesranf.2023.89.02.02
Sara López-Oliva, A. M. Puga, Carmela Maza-Albarrán, Ana M Montero-Bravo, M. L. Samaniego-Vaesken, Mar Ruperto, T. Partearroyo, G. Varela-Moreiras
Introduction: Elderly people on chronic drug treatment are one of the population groups with the highest risk of developing alterations in hydration status. One of the drugs most consumed by this population group and that can trigger the onset of dehydration are statins. However, up to date, these interactions have not been studied in depth. Objective: The objective of this study was to evaluate the influence of chronic statin consumption on hydration status in elderly people attending the community pharmacy. Methods: A case-control study was conducted in volunteers aged between 60 and 79 years living in Madrid, chronic statin users (cases) and patients of the same age range, non-users of statin drugs. chronic form (controls). Results: Analysis of general population data revealed a high prevalence of overweight and obesity, as well as a high percentage of body fat. On the other hand, the urinalysis showed a better hydration status of women compared to men. Regarding the effect of statins on hydration status, it was observed that the different parameters analyzed in patients on chronic statin treatment were indicative of dehydration, compared to the adequate hydration status of patients without treatment. These results were confirmed by analyzing the prevalence of dehydration in the different groups. Conclusions: The importance of monitoring the chronic consumption of drugs, such as statins, in the elderly, to avoid the development of pathologies, including the appearance of dehydration and its associated complications, is concluded from the present study. Community pharmacists as expert professionals in the medication are the most suitable professionals to carry out this follow-up.
简介:长期接受药物治疗的老年人是水合状态发生变化风险最高的人群之一。他汀类药物是这类人群服用最多的药物之一,也是可能引发脱水的药物。然而,迄今为止,尚未对这些相互作用进行深入研究。研究目的本研究旨在评估长期服用他汀类药物对社区药房就诊老年人水合状态的影响。方法: 采用病例对照研究的方法:对居住在马德里、年龄在 60 至 79 岁之间的他汀类药物长期使用者(病例)和同年龄组非他汀类药物长期使用者(对照)志愿者进行了病例对照研究。结果显示对普通人群数据的分析表明,超重和肥胖的发病率很高,身体脂肪的比例也很高。另一方面,尿液分析显示女性的水合状态优于男性。关于他汀类药物对水合状态的影响,与未接受他汀类药物治疗的患者的充足水合状态相比,对长期接受他汀类药物治疗的患者的不同参数进行的分析表明,患者存在脱水现象。通过分析不同组别中的脱水率,证实了这些结果。结论从本研究中可以得出结论:监测老年人长期服用他汀类药物等药物的情况,以避免出现病变,包括脱水及其相关并发症,具有重要意义。社区药剂师作为药物治疗方面的专业人员,是进行这种跟踪的最合适的专业人员。
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引用次数: 0
Novel Drugs Recently Authorized by EMA and FDA (Q2, 2023) 最近获得 EMA 和 FDA 批准的新药(2023 年第二季度)
Q Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-30 DOI: 10.53519/analesranf.2023.89.02.10
Santiago Cuéllar Rodríguez
EMA (EUROPEAN MEDICINES AGENCY): (A) TRACTO ALIMENTARIO Y METABOLISMO: Cipaglucosidasa Alfa (Pombiliti®): enfermedad de Pompe. Pegunigalsidasa Alfa (Elfabrio®): enfermedad de Fabry. Velmanasa Alfa (Lamzede®): alfa manosidosis. (B) SANGRE Y SISTEMA HEMATOPOYÉTICO: Vadadustat (Vafseo®): anemia por insuficiencia renal. (D) DERMATOLOGÍA: Ruxolitinib (Opzelura®): vitíligo. (J) ANTIINFECCIOSOS SISTÉMICOS: Vacuna COVID-19 recombinante (Bimervax®): COVID-19. Vacuna Virus Respiratorio Sincitial (Arexvy®): Virus respiratorio sincitial. (L) AGENTES ANTINEOPLÁSICOS E INMUNOMODULADORES: Ivosidenib (Tibsovo®): leucemia mieloide aguda. Mirikizumab (Omvoh®): Colitis ulcerosa.FDA (U.S. FOOD & DRUG ADMINISTRATION): (A) TRACTO ALIMENTARIO Y METABOLISMO: Esporas de microbiota fecal viva (Vowst®): recurrencia de infección por Clostridioides difficile . (B) SANGRE Y SISTEMA HEMATOPOYÉTICO: Efanesostocog alfa (Altuviiio®): hemofilia. Omidubicel (Omisirge®): trasplante de sangre de cordón umbilical. (D) DERMATOLOGÍA: Beremagene Geperpavec (Vyjuzek®): epidermolisis ampollosa. (G) SISTEMA GENITOURINARIO Y HORMONAS SEXUALES: Fezolinetant (Veozah®): sofocos asociados a menopausia. (J) ANTIINFECCIOSOS SISTÉMICOS: Rezafungina (Rezzayo®): candidiasis invasiva. Durlobactam/Sulbactam (Xacduro®): neumonía por Acinetobacter. (L) AGENTES ANTINEOPLÁSICOS E INMUNOMODULADORES: Ratifanlimab (Zynyz®): carcinoma de células de Merkel. Leniolisib (Joenja®): síndrome de PI3K-delta activado. Epcoritamab (Epkinly®): linfoma de células B. Glofitamab (Columvi®): linfoma de células B. (N) SISTEMA NERVIOSO: Tofersen (Qalsody®): esclerosis lateral amiotrófica. (S) ÓRGANOS SENSORIALES: Perfluorohexiloctano (Miebo®): ojo seco. (V) VARIOS: Flotufolastat F-18 (Posluma®): diagnóstico por imagen (PET).
EMA(欧洲药品管理局):(A) 食物链和代谢:Cipaglucosidase Alfa (Pombiliti®):庞贝氏症。Pegunigalsidase Alpha(Elfabrio®):法布里病。Velmanase Alpha (Lamzede®):α-甘露糖苷酶病。 (B) 血液和造血系统:Vadadustat (Vafseo®):肾功能衰竭引起的贫血。 (D) 皮肤病:Ruxolitinib (Opzelura®):白癜风。 (J) 全身性抗感染药物:重组 COVID-19 疫苗 (Bimervax®):COVID-19。呼吸道合胞病毒疫苗(Arexvy®):呼吸道合胞病毒。 (L) 抗线粒体和免疫调节剂:Ivosidenib(Tibsovo®):急性髓性白血病。FDA(美国食品和药物管理局):(A)食物链和代谢:粪便微生物群活孢子(Vowst®):艰难梭菌感染复发。 B)血液和造血系统:Efanesostocog alfa(Altuviiio®):血友病。Omidubicel(Omisirge®):脐带血移植。 (D) 皮肤科:Beremagene Geperpavec(Vyjuzek®):表皮松解症。(G) 生殖系统和性激素:Fezolinetant (Veozah®): 与更年期有关的潮热。 (J) 全身抗感染药物:Rezafungin (Rezzayo®): 侵袭性念珠菌病。Durlobactam/Sulbactam (Xacduro®): Acinetobacter pneumonia。 (L) 抗线粒体和免疫增强剂:Ratifanlimab (Zynyz®): Merkel 细胞癌。Leniolisib (Joenja®): 活化 PI3K-delta 综合征。Epcoritamab (Epkinly®):B 细胞淋巴瘤。Glofitamab (Columvi®):B 细胞淋巴瘤。 (N) 神经系统:Tofersen (Qalsody®):肌萎缩侧索硬化症。 (S) 感觉器官:Perfluorohexyloctane (Miebo®):干眼症。 (V) 其他:Flotufolastat F-18 (Posluma®):诊断成像(PET)。
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引用次数: 0
Smart medicines and medical devices: Opportunity or chimera? 智能药物和医疗设备:机遇还是假象?
Q Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-30 DOI: 10.53519/analesranf.2023.89.02.08
Angel Concheiro Nine
Medicines and medical devices capable of controlling the release of drugs and active substances in response to stimuli can significantly improve the therapeutic efficacy of treatments already implemented and open up new possibilities for advancing in the field of personalized medicine. Stimulus-responsive systems enable precise delivery of active substances at the right place and time and at the most convenient rate using lower doses than are required using conventional strategies. Advances in this field are directly linked to the evolution of materials science that makes it possible to have biomaterials and excipients that are not only bioactive but also modulators of the biological response. Activation-modulated and feedback-regulated controlled-release systems, based on bioinspired approaches, have already demonstrated their potential in the preclinical phases. The successful clinical use of some of them is an encouragement to continue advancing in this field.
能够根据刺激控制药物和活性物质释放的药物和医疗设备可显著提高已实施治疗的疗效,并为推进个性化医疗领域的发展开辟了新的可能性。与传统方法相比,刺激响应系统能以更低的剂量,在适当的时间和地点,以最方便的速度,精确地输送活性物质。这一领域的进步与材料科学的发展直接相关,材料科学的发展使得生物材料和辅料不仅具有生物活性,还能调节生物反应。基于生物启发方法的活化调节和反馈调节控释系统已在临床前阶段证明了其潜力。其中一些药物在临床上的成功应用鼓励我们继续在这一领域取得进展。
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引用次数: 0
Active cannabinoid nanocarriers for the treatment of atherosclerosis 用于治疗动脉粥样硬化的活性大麻素纳米载体
Q Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-30 DOI: 10.53519/analesranf.2023.89.02.06
Lucía Martín-Navarro, Lucía Martín-Banderas, María Dolores Herrera
In order to selectively deliver cannabinoid drugs (CB2 agonists) to the atherosclerotic plaque, biocompatible and biodegradable nanoparticles have been obtained. For this purpose, the PEGylated nanoparticles have been functionalized with a peptide capable of selectively binding to endothelial adhesion proteins overexpressed in the atherosclerotic plaque (vascular cell adhesion molecules 1, VCAM-1). The particles have been characterized physicochemically, in vitro in cell cultures and in vivo in an animal model of atherosclerosis (apolipoprotein E-deficient ApoE-/- mice), demonstrating optimal spatiotemporal control of cannabinoid release and superior pharmacological response. Given that CB2 agonist drugs present high lipophilicity and low availability, the introduction of selective nanosystems for the vehiculation of these antiatherogenic drugs would improve their bioavailability and efficacy. The work presented shows part of the results obtained from a previous project. These results have supported us for the award of a new funding grant to address a more advanced strategy involving the introduction of diagnostic elements and a phytocannabinoid.
为了有选择性地向动脉粥样硬化斑块输送大麻素药物(CB2 激动剂),我们获得了生物相容性和可生物降解的纳米颗粒。为此,PEG 化纳米粒子被一种肽功能化,该肽能够选择性地与动脉粥样硬化斑块中过度表达的内皮粘附蛋白(血管细胞粘附分子 1,VCAM-1)结合。这种微粒在理化、体外细胞培养和体内动脉粥样硬化动物模型(缺乏载脂蛋白 E 的载脂蛋白 E-/- 小鼠)中均有表征,显示出最佳的大麻素释放时空控制和卓越的药理反应。鉴于 CB2 激动剂药物具有高亲脂性和低可用性,采用选择性纳米系统来载体化这些抗动脉粥样硬化药物将提高其生物利用度和疗效。此次展示的工作是之前一个项目的部分成果。这些成果为我们获得新的资助提供了支持,以解决涉及引入诊断元素和植物大麻素的更先进战略问题。
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引用次数: 0
Trichomonas vaginalis: diagnosis of a forgotten sexually transmitted infection 阴道毛滴虫:诊断一种被遗忘的性传播感染
Q Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-30 DOI: 10.53519/analesranf.2023.89.02.01
Judit Ester Méndez Izquierdo, Cristina Fonseca Berzal, Alexandra Ibáñez Escribano
Trichomonas vaginalis is the protozoan parasite causative of one of the curable sexually transmitted infections that shows the highest annual incidence worldwide. However, the diagnostic methods most frequently used, are not sensitive enough and therefore, a large percentage of cases are not detected, especially in asymptomatic people. These traditional tests are not fast enough, and most of them are not suitable for carrying out diagnosis in men, with the consequent aggravation of the situation. In the last decades, new diagnostic techniques for trichomoniasis have been developed, which show much more acceptable sensitivity and specificity values, making it possible to reduce the time to diagnosis. Accordingly, their implementation could lead to a result in a few hours and thus, facilitate the start of treatment in those cases in which it is needed. In this framework, a bibliographic review of the most relevant techniques is carried out in the present work, including tests that are available for diagnosis in men, as well as for the detection of co-infections, highlighting their usefulness and both the advantages and disadvantages of each one.
阴道毛滴虫是一种原生动物寄生虫,是可治愈的性传播疾病之一,每年在全世界的发病率最高。然而,最常用的诊断方法不够灵敏,因此有很大一部分病例没有被检测出来,尤其是在无症状的人群中。这些传统的检测方法不够快速,而且大多数都不适合对男性进行诊断,结果导致病情加重。近几十年来,滴虫病的新诊断技术不断发展,其灵敏度和特异性大大提高,从而缩短了诊断时间。因此,采用这些技术可以在几小时内得出结果,从而有助于在需要治疗的情况下开始治疗。在这一框架下,本研究对最相关的技术进行了文献综述,包括可用于诊断男性以及检测合并感染的检测方法,强调了它们的实用性以及每种方法的优缺点。
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引用次数: 0
A profession, a (bio)ethics. A conceptual vision 一种职业,一种(生物)伦理。概念愿景
Q Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-30 DOI: 10.53519/analesranf.2023.89.02.04
A. F. Pinto Marques
The pharmaceutical profession has a unique scope of intervention in the area of health, where the pharmacist can be found in all domains related to access to health care, at its most varied levels. All this scope is based on a broad academic training, where scientific knowledge and expertise confer skills that are directly reflected on the pharmaceutical profession and practice. The professional practice of the pharmacist is very diverse and can be observed in various circumstances, from direct contact with the patient, with the person, as in community pharmacy, hospital pharmacy, clinical analysis laboratory, palliative or continuous care, in nursing homes, to in more reserved situations, such as in the laboratory or in scientific and clinical research. This wide range of activity of the pharmacist, supported by individual labor relations or integrated into multidisciplinary health teams, requires from him an assertive behavior and a (bio)ethical awareness that allows him to respond to the different demands he faces in his daily life. It is important, therefore, to reflect on the concepts and assumptions that ethics or bioethics have in the professional life of pharmacist, in the area of health and life sciences, and in the personal life of each one.
药剂专业在卫生领域具有独特的干预范围,药剂师可以在与获得医疗保健有关的所有领域,在最不同的层面上发挥作用。所有这些领域都以广泛的学术培训为基础,科学知识和专业技能直接反映在药剂专业和实践中。药剂师的专业实践非常多样化,可以在各种情况下观察到,从与病人和个人的直接接触,如在社区药房、医院药房、临床分析实验室、姑息治疗或持续护理、疗养院,到在较为隐蔽的情况下,如在实验室或在科学和临床研究中。药剂师的活动范围如此之广,既有个人劳动关系的支持,也有多学科医疗团队的参与,这就要求药剂师具有果断的行为和(生物)伦理意识,以应对日常生活中面临的不同需求。因此,有必要思考伦理或生物伦理在药剂师职业生活、健康和生命科学领域以及每个人的个人生活中的概念和假设。
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引用次数: 0
The “Academia de farmacia Santa María de España de la región de Murcia”: origin and history 穆尔西亚地区西班牙圣玛丽亚农学院":起源和历史
Q Pharmacology, Toxicology and Pharmaceutics Pub Date : 2023-06-30 DOI: 10.53519/analesranf.2023.89.02.03
S. Moreno Grau
The founding of Regional Academies is a consequence of these regions assuming the constitutional authority to “foment culture and research.” The “Academia de Farmacia Santa María de España de la Región de Murcia” was founded in 2002 as a result of this authority. Its name calls to mind the military order founded in 1270 by Alfonso X el Sabio, who was closely connected to the Region of Murcia. The emblem of the Academy depicts two decorated shields. One of the shields has an eight-pointed star with Saint Mary holding Jesus in one arm and the bowl of Hygieia in the other. “Fechos allend mar” is written on the bottom and “strela do dia” on the top. The other shield has the name of the Academy in gold letters. Over the space between the two shields are seven crowns referring to the seven times Murcia was a kingdom. The Academy has inherited an Academic tradition related to the Health Sciences that has been present in Cartagena since the 17th century. This tradition includes the “Academia Médico Práctica”; the “Academia Médico-Farmacéutica” and the “Academia Médico-Quirúrgica”. The “Academia Médico Práctica” was established around 1740. Information about this Academy can be found in Anastasio Chinchilla’s work and, between 1786 and 1788, in the Semanario Literario y Curioso de Cartagena, which is an interesting publication we will refer to briefly. King Carlos IV authorized an Academy with the same name to be founded in 1803 by Royal Decree, and we have sporadic information about this Academy throughout the first half of the 19th century. In 1880, the “Academia Médico-Farmacéutica” of Cartagena was established as a restructuring of the Medical-Pharmaceutical Association founded in the city in 1874 after the devastation of the Cantonal Rebellion. This Academy was active until separate Medical and Pharmaceutical Associations were authorized in 1900 for Cartagena and La Unión. In 1929, the “Academia Médido-Quirúrgica” was created, maintaining ties with the Medical-Pharmaceutical Association. Both the “Academia Médico-Farmacéutica” and that of Physicians and Surgeons had their own publications. The “Academia Médico-Farmacéutica” published a journal called The Union of Medical Science in Cartagena between 1881 and 1887. The “Academia Médico-Quirúrgica” published Medical News in Murcia, where information about the Academy appeared in 1929 and 1930. As can be seen, the “Academia de Farmacia Santa María de España de la Región de Murcia” has inherited its vocation for science and dissemination from these Academies.
地区学院的成立是这些地区承担 "促进文化和研究 "的宪法权力的结果。2002 年成立的 "穆尔西亚大区西班牙圣玛丽亚农学院 "就是在这一授权下成立的。它的名字让人联想到 1270 年由阿方索十世-萨比奥创建的军事教团,阿方索十世与穆尔西亚大区关系密切。学院的徽章描绘了两块经过装饰的盾牌。其中一面盾牌上有一颗八角星,圣玛丽亚一手抱着耶稣,一手拿着 Hygieia 碗。下方写着 "Fechos allend mar",上方写着 "strela do dia"。另一个盾牌上有金色的学院名称。两个盾牌之间的空白处有七个皇冠,意指穆尔西亚曾是一个王国。学院继承了卡塔赫纳自 17 世纪以来与健康科学有关的学术传统。这一传统包括 "实用医学科学院"、"农业医学科学院 "和 "奎鲁格医学科学院"。医学实践学院 "成立于 1740 年左右。有关该学院的信息可以在阿纳斯塔西奥-钦奇利亚的著作中找到,1786 年至 1788 年间,还可以在《卡塔赫纳文学与古玩研讨会》(Semanario Literario y Curioso de Cartagena)中找到。国王卡洛斯四世于 1803 年颁布敕令,授权成立了同名学院,在整个 19 世纪上半叶,我们都能获得有关该学院的零星信息。1880 年,卡塔赫纳的 "医学-农业科学院 "成立,它是 1874 年广州叛乱后在该市成立的医学-制药协会的重组。该学院一直活跃到 1900 年卡塔赫纳和拉乌尼翁分别成立医学和药学协会。1929 年,卡塔赫纳成立了 "奎鲁格医学研究院",与医学制药协会保持联系。医学-农业科学院 "和 "内科与外科医生科学院 "都有自己的出版物。1881 至 1887 年间,"医学-农业科学院 "在卡塔赫纳出版了一份名为《医学科学联盟》的期刊。1929 年和 1930 年,"Academia Médico-Quirúrgica "在穆尔西亚出版了《医学新闻》,刊登了学院的相关信息。可以看出,"穆尔西亚大区西班牙圣玛丽亚农学院 "继承了这些学院的科学和传播使命。
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引用次数: 0
Santiago Grisolía and Kansas City 圣地亚哥Grisolía和堪萨斯城
Q Pharmacology, Toxicology and Pharmaceutics Pub Date : 2022-12-31 DOI: 10.53519/analesranf.2022.88.04.01
M. Cascales Angosto
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引用次数: 0
Application of the Montecarlo Simulation for risk assessment in the Development of an analytical method according to the principles of quality by design (QbD) 蒙特卡罗模拟在风险评估中的应用基于设计质量原则的分析方法
Q Pharmacology, Toxicology and Pharmaceutics Pub Date : 2022-12-31 DOI: 10.53519/analesranf.2022.88.05.03
Fernando Ferrándiz Vindel
Montecarlo simulation is a powerful tool to identify influencing factors and intervals in which to carry out analytical development tests, although as it is a mathematical model, it must be experimentally confirmed. The results obtained and presented in the work confirm that this tool allows the previous analysis of the sources of analytical variability and its importance within the risk assessment phase. With this, the subsequent experimental confirmation must be mainly focused on the use of the variables revealed with the Montecarlo simulation, saving resources and time that do not add value to the global process of analytical development.Keywords: Montecarlo simulation; QbD; analytical method
蒙特卡罗模拟是确定进行分析开发测试的影响因素和时间间隔的有力工具,尽管它是一种数学模型,必须经过实验证实。在工作中获得和提出的结果证实,该工具允许对分析变异性的来源及其在风险评估阶段的重要性进行先前的分析。因此,随后的实验确认必须主要集中在蒙特卡罗模拟所揭示的变量的使用上,从而节省不为分析发展的全球过程增加价值的资源和时间。关键词:蒙特卡罗仿真;QbD;分析方法
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引用次数: 0
期刊
Anales De La Real Academia Nacional De Farmacia
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