共查询到20条相似文献,搜索用时 96 毫秒
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生物仿制药现状与发展趋势分析 总被引:1,自引:0,他引:1
生物仿制药是指原研生物药物在专利保护到期后,其他企业利用已有的数据进行简化生产并被批准上市的、与原研药物在结构和质量上非常相似、具有相当的生物活性和生物等效性的生物制药产品。相比于化学药,生物药通常分子量大且结构复杂,因而生物药的仿制往往难度较大,是系统工程,涉及的靶点选择、工程菌的构建、培养基的筛选、大规模培养体系的建立、分离纯化体系的建立、药物后修饰等诸多环节均有较高的技术壁垒;加上生物仿制药在审批过程中不仅需要临床Ⅰ期的药效和药代动力学试验来证明生物等效性外,还需要临床Ⅲ期试验来证明生物仿制药大范围使用后的疗效、不良反应、药物间的相互作用等,因此生物仿制药的研发成本较化学仿制药高,研发周期和审批周期也相对较长。 相似文献
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Nallagundla H. S. Reddy Srinivas Patnala Raimar Löbenberg Isadore Kanfer 《AAPS PharmSciTech》2014,15(5):1076-1086
Biowaivers are recommended for immediate-release solid oral dosage forms using dissolution testing as a surrogate for in vivo bioequivalence studies. Several guidance are currently available (the World Health Organization (WHO), the US FDA, and the EMEA) where the conditions are described. In this study, definitions, criteria, and methodologies according to the WHO have been applied. The dissolution performances of immediate-release metronidazole, zidovudine, and amoxicillin products purchased in South African and Indian markets were compared to the relevant comparator pharmaceutical product (CPP)/reference product. The dissolution performances were studied using US Pharmacopeia (USP) apparatus 2 (paddle) set at 75 rpm in each of three dissolution media (pH1.2, 4.5, and 6.8). Concentrations of metronidazole, zidovudine, and amoxicillin in each dissolution media were determined by HPLC. Of the 11 metronidazole products tested, only 8 could be considered as very rapidly dissolving products as defined by the WHO, whereas 2 of those products could be considered as rapidly dissolving products but did not comply with the f2 acceptance criteria in pH 6.8. All 11 zidovudine products were very rapidly dissolving, whereas in the case of the 14 amoxicillin products tested, none of those products met any of the WHO criteria. This study indicates that not all generic products containing the same biopharmaceutics classification system (BCS) I drug and in similar strength and dosage form are necessarily in vitro equivalent. Hence, there is a need for ongoing market surveillance to determine whether marketed generic products containing BCS I drugs meet the release requirements to confirm their in vitro bioequivalence to the respective reference product.KEY WORDS: BCS, dissolution testing, generic drug, immediate-release solid oral dosage forms, WHO criteria 相似文献
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根据 FDA 和 CFDA 口服固体制剂溶出度试验技术指导原则的要求,为防止仿制药一致性评价过程中相似因子(f2)法的滥用和 不恰当应用,采用样本数据实例演示的方式说明多变量置信区间法和模型依赖法作为补充手段在溶出曲线相似性比较和 BE 风险预评估中 的重要性。 相似文献
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Giorgio L. Colombo Enrico Agabiti-Rosei Alberto Margonato Claudio Mencacci Carlo Maurizio Montecucco Roberto Trevisan 《PloS one》2013,8(12)
The scientific documentation supporting the potential clinical and economic benefits of a growing use of off-patent generic drugs in clinical practice seems to be limited in Italy as yet.
Methods
We compared differences in outcomes between off-patent generic drugs and off-patent brand drugs in real clinical practice. The outcomes were: persistence and compliance with therapy, mortality, and other health resources consumption (hospitalizations, specialist examinations, other drugs) and total costs. Retrospective analysis was carried out by using the administrative databases of five Local Healthcare Units (ASLs - Aziende Sanitarie Locali) in the Lombardy Region of Italy. Data from the five ASLs were aggregated through a meta-analysis, which produced an estimate indicator of the mean or percentage difference between the two groups (branded vs. generic) and their respective significance tests. The therapeutic areas and studied drugs were: diabetes: metformin - A10BA02; hypertension: amlodipine - C08CA01; dyslipidemia: simvastatin - C10AA01; psychiatry: sertraline - N06AB06; cardiology: propafenone - C01BC03; osteoporosis: alendronate - M05BA04.Results
The 5 Local Healthcare Units (ASL) represent a population of 3,847,004 inhabitants. The selected sample included 347,073 patients, or 9.02% of the total ASL population; 67% of the patients were treated with off-patent brand drugs. The average age was 68 years, with no difference between the two groups. After 34 months of observation, compliance and persistence were in favor to generic drugs in all therapeutic areas and statistically significant in the metformin, amlodipine, simvastatin, and sertraline groups. The clinical outcomes (hospitalizations, mortality, and other health costs) show no statistically significant differences between off-patent generic vs. off-patent brand medicines.Conclusions
Off-patent generic drugs appear to be a therapy option of choice in Italy as well, based on clinical outcomes and economic consequences, both for the National Health Service and patients, considering that the price difference between brand and generic drugs is completely charged on patients. 相似文献14.
本文以临床上广泛而典型的六种解热镇痛药:对乙酰氨基酚、阿司匹林、布洛芬、萘普生、安乃近和双氯芬酸为例,概括了其理化性质及研究概况,综述了近年来该六种解热镇痛药的制剂学研究新进展,介绍了各类新剂型的应用情况,并对其未来发展趋势进行展望,为该类药物的制剂研发工作提供思路。 相似文献
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有关物质是药品的关键质量属性之一,也是仿制药一致性评价的重要内容,其涉及药品的安全性及其质量的可控性。文章梳理了 仿制药有关物质的来源及研究重点,评估仿制药有关物质的文献分析方法,总结归纳仿制药与被仿制药实际样品的杂质谱分析比较及其 意义,探讨杂质限度的确定原则与方法。 相似文献
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药物经济学评价作为新兴学科,在目前如火如荼的仿制药一致性评价中得到广泛关注。文章在简介药物经济学评价基本方法的基础 上,对制药企业在仿制药一致性评价过程中的经济学问题及对策进行了探讨。 相似文献
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G G Egorenko V V Berezhinskaia G V Dolgova T P Svinogeeva L A Shtegel'man E Z Kagan A V Nikitin 《Antibiotiki i khimioterapii͡a》1990,35(9):26-27
Gentacycol is a local dosage form of gentamicin based on collagen for implantation to wounds in treatment of patients with infections of soft tissues and prevention of contamination of open injuries of the bones and soft tissues. General toxic and organotropic properties of gentacycol were studied on animals with subcutaneous implantation of the dosage form in doses equivalent to the therapeutic dose for man and exceeding it 2-fold. The study showed that the dosage form had no unfavourable side effects on the animal general state, hearing, the functional state of the liver and kidneys and the peripheral blood. In the doses tested gentacycol did not influence the indices of the cardiovascular system and neuromuscular conduction. Morphological examination of the skin and hypodermic tissues in the implantation site revealed no damaging action of the dosage form on the surrounding tissues. 相似文献
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A revolutionary paradigm shift is being observed currently, towards the use of therapeutic biologics for disease management. The present research was focused on designing an efficient dosage form for transdermal delivery of α-choriogonadotropin (high molecular weight biologic), through biodegradable polymeric microneedles. Polyvinylpyrrolidone-based biodegradable microneedle arrays loaded with high molecular weight polypeptide, α-choriogonadotropin, were fabricated for its systemic delivery via transdermal route. Varied process and formulation parameters were optimized for fabricating microneedle array, which in turn was expected to temporally rupture the stratum corneum layer of the skin, acting as a major barrier to drug delivery through transdermal route. The developed polymeric microneedles were optimized on the basis of quality attributes like mechanical strength, axial strength, insertion ratio, and insertion force analysis. The optimized polymeric microneedle arrays were characterized for in vitro drug release studies, ex vivo drug permeation studies, skin resealing studies, and in vivo pharmacokinetic studies. Results depicted that fabricated polymeric microneedle arrays with mechanical strength of above 5 N and good insertion ratio exhibited similar systemic bioavailability of α-choriogonadotropin in comparison to marketed subcutaneous injection formulation of α-choriogonadotropin. Thus, it was ultimately concluded that the designed drug delivery system can serve as an efficient tool for systemic delivery of therapeutic biologics, with an added benefit of overcoming the limitations of parenteral delivery, achieving better patient acceptability and compliance. 相似文献
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In the United States (U.S.), an authorized generic (AG) drug is essentially the approved brand-name drug (i.e., innovator drug), but marketed with a different name. Like independent generics, authorized generics (AGs) generally tend to cost less than their brand name counterpart, even though AGs are essentially identical to the brand. Most patients and health professionals are unaware of the availability of AGs even though they are commonplace. The launch of an AG has a financial impact on patients and on the competitive landscape of the pharmaceutical industry. Information regarding AGs is limited. The purpose of this study is to familiarize the reader with AGs. A review of the government documents and literature was conducted. The marketing of AGs has resulted, but not always, in benefits to the patient. AGs have been used as a tool in agreements between brand and generic companies. Countries have differing allowance and approval policies for AGs. AGs have played an important role in the healthcare system. 相似文献