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LC-MS/MS AND GC-MS PROFILING AND THE ANTIOXIDANT ACTIVITY OF CARISSA CARANDAS LINN. FRUIT EXTRACTS lc-ms/ms 和 gc-ms 图谱以及 carissa carandas linn.果实提取物
Pub Date : 2024-06-01 DOI: 10.22159/ijpps.2024v16i6.50818
D. Sudha, R. Malarkodi, A. Gokulakrishnan, A. R. LIYAKATH ALI
Objective: The present study was carried out with three varieties (green, pink, and sweet) of Carissa carandas fruit extract for the identification of phytochemical constituents in C. carandas fruit extracts using Liquid Chromatography-Mass Spectrometry (LC-MS/MS) and Gas Chromatography-Mass Spectrometry (GCMS)Methods: LC MS/MS and GCMS analysis were adopted to study three varieties of C. carandas fruit, namely green, pink, and sweet, using different solvent extractions such as ethanol, methanol, and aqueous.Results: High levels of phenolic acids and flavonoids in the green variety were beneficial for anti-diabetic activity due to their antioxidant properties. Among the three varieties of tested samples, the maximum concentration was observed in the ethanol extract of the green varieties (2.485 mg/g FW) compared to the ethanol extract of the pink (1.564 mg/g FW) and sweet (1.285 mg/g) varieties, respectively. Ethanol extract of the green variety has a high level of anthocyanin, which increases tolerance to disease. The separation and identification of fatty acids in C. carandas fruit were determined through analysis. The sweet C. carandas variety recorded the highest concentration of fatty acids (147.2 mg/100g FW) compared to the pink and green varieties (94.9 mg/100 g FW) and (72.79 mg/100 g FW), respectively, and could successfully identify the number of phytonutrients that have health benefits. Further work is being carried out, which may lead to the development of herbal medicine.Conclusion: The present study concludes that phytochemicals present in C. carandas fruit, extracted by LC-MS and GC MS analysis, contain antioxidant and anti-diabetic effects.
研究目的本研究采用液相色谱-质谱法(LC-MS/MS)和气相色谱-质谱法(GCMS)对三个品种(绿色、粉色和甜色)的 Carissa carandas 果实提取物中的植物化学成分进行鉴定:采用液相色谱-质谱(LC-MS/MS)和气相色谱-质谱(GCMS)分析方法,使用乙醇、甲醇和水溶液等不同溶剂萃取法,研究了绿色、粉色和甜色三个品种的 C. carandas 果实:结果:绿色品种中的酚酸和类黄酮含量较高,具有抗氧化作用,有利于抗糖尿病。在三个品种的测试样品中,绿色品种乙醇提取物中的酚酸浓度最高(2.485 毫克/克脂重),而粉色品种(1.564 毫克/克脂重)和甜味品种(1.285 毫克/克)乙醇提取物中的酚酸浓度分别为 1.564 毫克/克脂重和 1.285 毫克/克脂重。绿色品种的乙醇提取物中含有大量花青素,可提高抗病能力。通过分析确定了 C. carandas 果实中脂肪酸的分离和鉴定。与粉红和绿色品种(94.9 mg/100 g FW)和(72.79 mg/100 g FW)相比,甜 C. carandas 品种的脂肪酸浓度最高(147.2 mg/100 g FW),并能成功鉴定出对健康有益的植物营养素的数量。目前正在开展进一步的工作,这可能会促进草药的开发:本研究得出结论,通过 LC-MS 和 GC MS 分析提取的 C. carandas 果实中的植物化学物质具有抗氧化和抗糖尿病作用。
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引用次数: 0
UNLOCKING THE THERAPEUTIC POTENTIAL: EXPLORING NF-κB AS A VIABLE TARGET FOR DIVERSE PHARMACOLOGICAL APPROACHES 释放治疗潜力:探索 NF-κB 作为不同药物学方法的可行目标
Pub Date : 2024-06-01 DOI: 10.22159/ijpps.2024v16i6.49530
Ajeet Pal Singh, Ashish Kumar Sharma, Thakur Gurejet Singh
NF-κB is a vital transcription factor that responds to diverse stimuli like cytokines, infections, and stress. It forms different dimers, binds to specific DNA sequences, and regulates gene expression. It operates through two pathways: canonical (for inflammation and immunity) and non-canonical (for specific processes). These pathways tightly control activity of NF-κB and impacting gene expression. Aberrant NF-κB activation is linked to cancer and other diseases, making it a potential therapeutic target. This review explores the role of NF-κB in disease and its therapeutic potential in various conditions. Intricate signal transduction processes lead to NF-κB activation by phosphorylating IκB proteins, allowing NF-κB dimers to enter the nucleus and influence gene expression. This dynamic regulation involves co-activators and interactions with other transcription factors, shaping complex gene expression programs.Understanding the multifaceted functions off NF-κB is crucial as its deregulation is associated with a range of diseases, including cancer, autoimmune disorders, and inflammatory conditions. Exploring recent studies offers insights into potential therapeutic strategies aimed at modulating NF-κB activity to restore health and combat various pathological conditions. This Comprehensive review is based on the role of NF-κB in disease pathogenesis and therapeutic implications.
NF-κB 是一种重要的转录因子,可对细胞因子、感染和压力等各种刺激做出反应。它形成不同的二聚体,与特定的 DNA 序列结合,并调节基因表达。它通过两种途径发挥作用:典型途径(用于炎症和免疫)和非典型途径(用于特定过程)。这些途径严格控制 NF-κB 的活性,并影响基因表达。NF-κB 的异常激活与癌症和其他疾病有关,因此成为潜在的治疗靶点。本综述探讨了 NF-κB 在疾病中的作用及其在各种情况下的治疗潜力。错综复杂的信号转导过程通过磷酸化 IκB 蛋白导致 NF-κB 激活,使 NF-κB 二聚体进入细胞核并影响基因表达。这种动态调控涉及共激活因子以及与其他转录因子的相互作用,从而形成复杂的基因表达程序。了解 NF-κB 的多方面功能至关重要,因为它的失调与癌症、自身免疫性疾病和炎症等一系列疾病有关。对最新研究的探讨为旨在调节 NF-κB 活性以恢复健康和对抗各种病症的潜在治疗策略提供了见解。本综述基于 NF-κB 在疾病发病机制中的作用和治疗意义。
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引用次数: 0
A STUDY ON KNOWLEDGE OF ANIMAL BITE VICTIMS REGARDING ANIMAL BITE AND RABIES ATTENDING ANIMAL BITE OPD ASSOCIATED WITH GOVERNMENT MEDICAL COLLEGE DATIA, MADHYA PRADESH 与中央邦达蒂亚政府医学院相关的动物咬伤手术室开展的关于动物咬伤受害者对动物咬伤和狂犬病知识的研究
Pub Date : 2024-06-01 DOI: 10.22159/ijpps.2024v16i6.50961
Vikas Pandey, Kalpana Arya, Bikramjeet Mitra
Objective: The objective of the study is to assess the knowledge regarding animal bite, prevention and control and study the association of the socio-demographic factors with knowledge regarding animal bite, prevention and control.Methods: An observational cross-sectional study was conducted in 280 animal bite victims attending animal bite OPD associated with Govt. Medical College Datia, Madhya Pradesh, India. Information collected with the semi-structured questionnaire after obtaining informed verbal consent for study duration of 3 mo. Data pertaining regarding knowledge of animal bite victims, prevention and control to the socio-demographic profile of victim, category of bite, age, sex, education, occupation, residence was collected. Data was analyzed using MS Excel and Epi Info software.Results: Among 280 victims 178(63.57%) were males, 156(55.7%) belongs to 15-45 y, 170(60.71%) were living in urban area, and 98(35%) and 89(31.7%) of the victims were agriculture worker and laborers respectively. 263(93.92%) victims bitten by dog of them 249(88.9%) by street dog, 221(78.92%) had Category III bite, lower extremity was affected in 280(75.71%), and 156(55.71%) of the victims were affected during evening hours.Conclusion: There is need for creating awareness in public and medical community about proper wound management and judicious use of anti-rabies vaccine.
研究目的本研究旨在评估有关动物咬伤、预防和控制的知识,并研究社会人口因素与动物咬伤、预防和控制知识之间的关联:在印度中央邦达提亚政府医学院动物咬伤门诊部就诊的 280 名动物咬伤受害者中开展了一项观察性横断面研究。在获得知情口头同意后,通过半结构式问卷收集信息,研究持续 3 个月。收集的数据涉及动物咬伤受害者的知识、预防和控制、受害者的社会人口概况、咬伤类别、年龄、性别、教育程度、职业和居住地。数据使用 MS Excel 和 Epi Info 软件进行分析:280名受害者中有178人(63.57%)为男性,156人(55.7%)年龄在15-45岁之间,170人(60.71%)居住在城市地区,98人(35%)和89人(31.7%)分别是农业工人和工人。263(93.92%)名受害者被狗咬伤,其中249(88.9%)名受害者被街狗咬伤,221(78.92%)名受害者被第三类狗咬伤,280(75.71%)名受害者被咬伤下肢,156(55.71%)名受害者在傍晚时分被咬伤:有必要提高公众和医疗界对正确处理伤口和合理使用抗狂犬病疫苗的认识。
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引用次数: 0
SELF-MEDICATION FOR PREVENTION AND TREATMENT OF DISEASES DURING COVID-19 PANDEMIC-A CROSS SECTIONAL SURVEY IN GENERAL POPULATION 科维德-19 大流行期间用于预防和治疗疾病的自我药疗--普通人群横断面调查
Pub Date : 2024-06-01 DOI: 10.22159/ijpps.2024v16i6.50520
Sarita Panigrahy, D. Dass, Sunil Kumar Pandey, Damera Meher Sheena
Objective: The goal of this study was to assess the pattern and reasons for self-medication during the COVID-19 pandemic.Methods: The present study was an exploratory cross-sectional survey. The questionnaire was meant to be filled up by those who were older than 18 y and could read and write English. The questionnaire (related to socio-demographic status, pattern, and reasons for self-medication) was designed and validated by a committee of faculties in the department of pharmacology through a peer review process and sent through mail, WhatsApp, and other means of social media. A non-parametric Chi-square test was used to test relationships between categorical variables.Results: The responses of 557 participants were analyzed; among them, the majority were females as compared to males. There was a significant difference (*p = 0.02) in the pattern of self-medication between the males (38%) and females (62%), and most of the participants used self-medication as a preventive measure for COVID-19 (39%). Fear of going out (13%) during COVID-19 was the main single reason for self-medication. Arsenic Album 30 was the most frequently used homeopathic formulation (26%).Conclusion: This study showed that apprehension, coupled with the COVID-19 pandemic, was the main impulse for self-medication.
研究目的本研究旨在评估 COVID-19 大流行期间自我用药的模式和原因:本研究是一项探索性横断面调查。问卷由 18 岁以上、能读写英语的人填写。问卷(涉及社会人口状况、自我用药模式和原因)由药理学系的一个教师委员会设计并通过同行评审程序确认,并通过邮件、WhatsApp 和其他社交媒体发送。采用非参数卡方检验法检验分类变量之间的关系:对 557 名参与者的回复进行了分析;其中,女性与男性相比占大多数。男性(38%)和女性(62%)的自我药疗模式存在明显差异(*p = 0.02),大多数参与者将自我药疗作为 COVID-19 的预防措施(39%)。害怕在 COVID-19 期间外出(13%)是自我药疗的主要单一原因。砷专辑 30 是最常用的顺势疗法配方(26%):这项研究表明,忧虑加上 COVID-19 大流行是自我药疗的主要动机。
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引用次数: 0
ADVANCES IN COCRYSTALS OF ANTICANCER AGENTS: FORMULATION STRATEGIES AND THERAPEUTIC IMPLICATIONS 抗癌剂共晶体的研究进展:配制策略和治疗意义
Pub Date : 2024-06-01 DOI: 10.22159/ijpps.2024v16i6.51044
Aparna Singh, Vishakha Jaiswal, Shradha Bisht
Cancer remains one of the most pressing health concerns worldwide, driving continuous efforts in pharmaceutical research to develop more effective treatments. In the ever-evolving landscape of cancer therapy, cocrystals stand as promising contenders, offering enhanced solubility, stability, and bioavailability to traditional anticancer agents. Co-crystallization, a strategy emerging at the nexus of pharmaceutical and crystal engineering. From the fundamental principles of cocrystal engineering to advanced spectroscopic and crystallographic methodologies, each aspect is meticulously dissected to unveil the transformative potential of cocrystals in oncology. The review elucidates the transformative potential of cocrystals in oncology, highlighting their capacity to revolutionize drug delivery and efficacy. Recent advancements in the field are comprehensively examined, showcasing the promising role of anticancer cocrystals in paving the way for novel therapeutic strategies and improved patient outcomes. Cocrystals represent a promising avenue in cancer therapy, offering significant enhancements to traditional anticancer agents. Through a comprehensive exploration of recent advancements, this article navigates the complex terrain of anticancer cocrystals, drug-drug cocrystals, paving the way for novel therapeutic strategies and improved patient outcomes.
癌症仍然是全球最紧迫的健康问题之一,推动着制药研究不断努力开发更有效的治疗方法。在不断发展的癌症治疗领域,共晶体是前景广阔的竞争者,它能提高传统抗癌药物的溶解度、稳定性和生物利用度。共晶体化是制药和晶体工程领域的一项新兴战略。从共晶体工程的基本原理到先进的光谱和晶体学方法,每个方面都进行了细致的剖析,以揭示共晶体在肿瘤学中的变革潜力。这篇综述阐明了共晶体在肿瘤学中的变革潜力,强调了它们彻底改变药物输送和疗效的能力。文章全面审视了该领域的最新进展,展示了抗癌球晶在为新型治疗策略和改善患者预后铺平道路方面的巨大作用。共晶体是癌症治疗的一个前景广阔的途径,可显著提高传统抗癌药物的疗效。本文通过对最新进展的全面探讨,介绍了抗癌共晶体、药物-药物共晶体的复杂性,为新型治疗策略和改善患者预后铺平了道路。
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引用次数: 0
FLAVONOIDS IN ACACIA CATECHU BARK EXTRACTS AND BIBLIOGRAPHIC ANALYSIS IN GUNA, MADHYA PRADESH, INDIA 印度中央邦古纳地区刺槐树皮提取物中的黄酮类化合物及文献分析
Pub Date : 2024-06-01 DOI: 10.22159/ijpps.2024v16i6.50939
Archana Tiwari, Avinash Tiwari
Objective: The objective of this work is to examine the overall flavonoid content in bark samples of Acacia catechu obtained from the Guna region of Madhya Pradesh, India, using several extraction methods. Furthermore, this study has incorporated current literature, conducted bibliographic analysis, examined co-authorship studies, and gathered other pertinent material to augment comprehension and underscore the importance of the research.Methods: For the purpose of this experiment, a total of thirty samples of test plants were gathered from the research region throughout various seasons. Each individual sample was prepared with six different solvents. Following this, a standardized laboratory technique was used to undertake quantitative testing. The bibliographic analysis was conducted using Dimension AI and VOS viewer software in the timeframe of 1975-2024 (till March 8, 2024).Results: Findings indicated that the polar organic solvents methanol, ethanol, acetone, and the aqueous extracts were shown to display a substantial quantity of flavonoids, chloroform extracts exhibited negligible and benzene extracts were found to be entirely devoid of the same. The comparative bibliographic investigations have confirmed the need to study the possible medicinal properties of test plants in the Guna region.Conclusion: This preliminary study has the potential to identify new, economically viable, and readily available sources of flavonoids, which are natural antioxidants present in the indigenous flora of the Guna region.
研究目的本研究的目的是采用多种提取方法,研究从印度中央邦古纳地区获得的刺槐树皮样本中黄酮类化合物的总体含量。此外,本研究还吸收了当前的文献,进行了文献分析,检查了共同作者的研究,并收集了其他相关材料,以加深理解并强调研究的重要性:为了进行这项实验,我们在研究地区的各个季节共采集了 30 个测试植物样本。每个样本都使用六种不同的溶剂进行制备。然后,使用标准化实验室技术进行定量测试。使用 Dimension AI 和 VOS 浏览器软件对 1975-2024 年(截至 2024 年 3 月 8 日)的文献进行了分析:研究结果表明,极性有机溶剂甲醇、乙醇、丙酮和水提取物中含有大量类黄酮,氯仿提取物中的类黄酮含量微乎其微,而苯提取物中则完全没有类黄酮。对比文献调查证实,有必要研究古纳地区试验植物可能具有的药用特性:这项初步研究有可能确定新的、经济上可行且易于获得的类黄酮来源,这些类黄酮是存在于古纳地区本地植物区系中的天然抗氧化剂。
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引用次数: 0
REGULATORY PERSPECTIVE FOR GENE THERAPY PRODUCTS IN THE USA, EU AND JAPAN AND FUTURE ASPECTS 美国、欧盟和日本对基因治疗产品的监管视角及未来展望
Pub Date : 2024-06-01 DOI: 10.22159/ijpps.2024v16i6.50806
B. P. K., SANGITA MISHRA, M. Venkatesh
Gene Therapy Products (GTPs) hold immense promise in revolutionizing medical treatments by altering genetic expressions to address various diseases. This study gives a summary of gene therapy products and their prospective uses, their historical development and several treatment options, as an in-depth exploration of the regulatory considerations for GTPs in the United States of America (USA), European Union (EU), and Japan, along with insights into future aspects of this field. A comprehensive discussion follows detailing the regulatory landscape and approval pathways in the USA, EU, and Japan. Programs that are exclusive to each area, such as PRIME (Priority Medicines) in the EU, USA's RMAT (Regenerative Medicines Advanced Therapy) designation and the Sakigake system in Japan are examined. Milestone meetings, approval requirements, and specific regulatory guidelines for GTPs in each region are also thoroughly covered. A list of approved GTPs and a glimpse into the future of the field. Anticipated trends include increasing investments, challenges related to production costs, expansion of manufacturing capabilities, and regulatory updates. The various regulatory strategies in each area and their efforts to balance patient access and safety will have a big impact on GTPs marketed in the future. Japan is well-positioned to maintain it’s as a global leader in regenerative medicine and cell treatments because of its favourable regulatory environment and government backing.
基因治疗产品(GTPs)通过改变基因表达来治疗各种疾病,在彻底改变医疗方法方面前景广阔。本研究概述了基因治疗产品及其未来用途、历史发展和几种治疗方案,深入探讨了美利坚合众国(美国)、欧盟(欧盟)和日本对基因治疗产品的监管考虑,并对这一领域的未来发展提出了见解。接下来的全面讨论将详细介绍美国、欧盟和日本的监管情况和审批途径。对每个地区独有的计划进行了研究,如欧盟的 PRIME(优先药品)、美国的 RMAT(再生医学高级疗法)指定和日本的 Sakigake 系统。此外,还详细介绍了各地区 GTP 的里程碑会议、审批要求和具体监管指南。获得批准的 GTP 列表以及该领域的未来展望。预计的趋势包括投资增加、与生产成本相关的挑战、制造能力的扩展以及监管更新。各地区的各种监管策略及其为平衡患者就医和安全性所做的努力将对未来上市的 GTP 产生重大影响。由于拥有良好的监管环境和政府支持,日本完全有能力保持其在再生医学和细胞治疗领域的全球领先地位。
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引用次数: 0
ENVIRONMENTAL IMPACT AND REGULATORY COMPLIANCE: A COMPREHENSIVE APPROACH IN MANAGING INSTITUTIONAL PHARMACEUTICAL WASTE 环境影响与法规遵从:管理机构医药废物的综合方法
Pub Date : 2024-06-01 DOI: 10.22159/ijpps.2024v16i6.50666
Sweta Gupta, Sonal Desai
Apart from the pharmaceutical industries, pharmaceutical institutes are also producing the various types of waste which is a complex issue and that raises several challenges to environmental sustainability as well as public health. Waste produced by pharmaceutical institutes includes chemicals, reagents, biological waste, papers, office supplies and electronic waste, etc. Key topics include the identification and classification of pharmaceutical waste which have potential harm to the ecosystem. Pharmaceutical waste can reach the environment through excretion and improper disposal methods which leads the water contamination, soil pollution and air emission. Surrounding environment directly affect the living things who suffers from infections and diseases from pharmaceutical waste materials. Regulatory frameworks play an important part in defining waste management protocols and proper waste depositories. Compliance with environmental laws and regulations pertaining to pharmaceutical waste disposal is an essential part of pharmacy management. The cost for regulatory compliance in the form of charges are paid by pharmaceutical institutes to comply various laws, rules and standards set by government agencies for waste management. If any institute are fails to comply with the standards of waste management, they have to pay penalties and fines for their improper handling of guidelines. The paper addresses advancements in waste treatment technologies, exploring innovative approaches like autoclaving, microwaving, plasma pyrolysis, incineration and chemical treatments. Understanding of the proper storage and disposal of garbage to prevent contamination and infection.
除制药业外,制药机构也会产生各种类型的废物,这是一个复杂的问题,对环境的可持续发展和公众健康提出了多项挑战。制药机构产生的废物包括化学品、试剂、生物废物、纸张、办公用品和电子废物等。关键议题包括对生态系统有潜在危害的制药废弃物的识别和分类。医药废物可通过排泄和不恰当的处置方法进入环境,导致水污染、土壤污染和空气污染。周围环境会直接影响生物,使其受到药物废料的感染而患病。监管框架在确定废物管理规程和适当的废物存放处方面发挥着重要作用。遵守与医药废物处理相关的环境法律法规是药房管理的重要组成部分。为遵守政府机构制定的各种废物管理法律、法规和标准,制药机构需要以收费的形式支付合规成本。如果任何机构未能遵守废物管理标准,就必须为其不当处理准则支付处罚和罚款。本文介绍了废物处理技术的进步,探讨了高压灭菌、微波、等离子热解、焚烧和化学处理等创新方法。了解垃圾的正确储存和处理,以防止污染和感染。
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引用次数: 0
A COST VARIATION COMPARISON AMONG ORAL ANTI-MIGRAINE DRUGS AVAILABLE IN THE INDIAN MARKET 印度市场上抗偏头痛口服药物的成本差异比较
Pub Date : 2024-05-01 DOI: 10.22159/ijpps.2024v16i5.50777
Akash Mishra, P. S. Mishra, Anjali Kushwah, Kamayani Gupta
Objective: Our study aimed to evaluate the cost percent variation and cost ratio of different brands of oral anti-migraine drugs available in Indian market.Methods: The cost of various commonly used oral anti-migraine drugs were taken from the latest issue of Current Index of Medical Specialities January 2022, Drug Today January-April 2022 and 1 mg online site. Cost percent variation and Cost ratio were calculated.Results: A total of 7 single anti-migraine drugs and 9 Fixed-Dose Combinations (FDCs) showed a wide range of cost variation. The highest cost percent variation of 433% was seen in Sumatriptan 50 mg with a cost ratio of 5.33, whereas Amitriptyline 10 mg showed the lowest cost percent variation of 47.9% with a cost ratio of 1.47. Among FDCs Naproxen 500 mg+Sumatriptan 85 mg showed the highest cost per cent variation of 400% with a cost ratio of 5.25 and Propranolol 40 mg+Flunarizine 10 mg showed the lowest cost per cent variation of 46.56% with a cost ratio of 1.46.Conclusion: Our study showed a wide variation in the cost of oral anti-migraine drugs available in the Indian market, which provides insight to the healthcare professional and gives Drug Price Control Order (DPCO) authorities to minimize the financial burden and improve patient compliance.
研究目的我们的研究旨在评估印度市场上不同品牌的抗偏头痛口服药物的成本百分比变化和成本比率:方法:从最新一期的《Current Index of Medical Specialities》(2022 年 1 月)、《Drug Today》(2022 年 1-4 月)和 1 mg 在线网站上获取各种常用口服抗偏头痛药物的成本。计算了成本百分比变化和成本比率:结果:共有 7 种单一抗偏头痛药物和 9 种固定剂量复方制剂(FDC)的成本差异较大。舒马曲普坦 50 毫克的成本变化率最高,达 433%,成本比为 5.33;阿米替林 10 毫克的成本变化率最低,为 47.9%,成本比为 1.47。在 FDCs 中,萘普生 500 毫克+舒马曲普坦 85 毫克的成本百分比差异最大,为 400%,成本比为 5.25;普萘洛尔 40 毫克+氟桂利嗪 10 毫克的成本百分比差异最小,为 46.56%,成本比为 1.46:我们的研究表明,印度市场上抗偏头痛口服药物的成本差异很大,这为医疗保健专业人士和《药品价格管理条例》(DPCO)制定机构提供了深入的见解,以最大限度地减轻患者的经济负担,提高患者的依从性。
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引用次数: 0
REGULATORY CHALLENGES AND LANDSCAPES OF MONOCLONAL ANTIBODY REGISTRATION: GLOBAL OUTLOOK 单克隆抗体注册的监管挑战与前景:全球展望
Pub Date : 2024-05-01 DOI: 10.22159/ijpps.2024v16i5.50723
Surjonarayan Motilal, Sangita Mishra, M. Arjun, M. Venkatesh
Objective: This review aims to illuminate the unprecedented growth and versatile therapeutic landscape of monoclonal antibody (mAb) products, highlighting their significant impact on diverse medical fields such as oncology, septicemia treatment, infection management, and substance abuse disorder interventions. This review outlines the challenges associated with the development, manufacturing, and regulatory approval of monoclonal antibodies, emphasizing the need for diligent attention to overcome these complexities. The review comprehensively examines the historical evolution and therapeutic applications of monoclonal antibodies, emphasizing their potent and versatile characteristics that have enabled successful interventions in challenging regulatory approvals. It delves into the critical considerations in manufacturing, regulatory navigation, and the strategic integration of expedited approval pathways, providing a holistic understanding of the intricate terrain of innovation, clinical translation, and impactful patient care in the realm of monoclonal antibody products. Monoclonal antibodies have significantly advanced medical treatment in various domains, revolutionizing cancer therapy, offering new avenues for septicemia management, augmenting the arsenal against infections, and opening novel pathways for addressing substance abuse disorders. Their development and regulatory approval are associated with challenges of scientific innovation, manufacturing, and regulatory compliance. Despite the challenges, monoclonal antibodies have demonstrated remarkable potential in addressing complex medical conditions. The review serves as a compass, guiding researchers, clinicians, and regulatory authorities through the intricate terrain of monoclonal antibody innovation and clinical translation. It emphasizes the need for diligent attention to overcome the complexities associated with their development and regulatory approval while highlighting their significant impact on advancing patient care.
目的:本综述旨在阐明单克隆抗体(mAb)产品前所未有的增长势头和多变的治疗前景,强调其对肿瘤学、败血症治疗、感染管理和药物滥用障碍干预等不同医疗领域的重大影响。本综述概述了与单克隆抗体的开发、生产和监管审批相关的挑战,强调了克服这些复杂性的必要性。综述全面考察了单克隆抗体的历史演变和治疗应用,强调了单克隆抗体的强效和多用途特性,这些特性使单克隆抗体能够成功干预具有挑战性的监管审批。报告深入探讨了生产、监管导航和加速审批途径战略整合等方面的关键考虑因素,提供了对单克隆抗体产品领域的创新、临床转化和有影响力的患者护理等错综复杂情况的全面了解。单克隆抗体极大地推动了各个领域的医学治疗,为癌症治疗带来了革命性的变化,为败血症治疗提供了新的途径,增强了抗感染的能力,并为解决药物滥用障碍开辟了新的途径。单克隆抗体的开发和监管审批面临着科学创新、生产和监管合规方面的挑战。尽管挑战重重,单克隆抗体在解决复杂的医疗问题方面已展现出非凡的潜力。这篇综述为研究人员、临床医生和监管机构提供了指南,引导他们在错综复杂的单克隆抗体创新和临床转化领域取得进展。它强调了在克服与单克隆抗体开发和监管审批相关的复杂性方面需要付出的努力,同时强调了单克隆抗体对促进患者治疗的重大影响。
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引用次数: 0
期刊
International Journal of Pharmacy and Pharmaceutical Sciences
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