美国简明药品申请程序及相关法律责任

简明药品申请是美国仿制药品的研制和生产者向美国FDA提出药品上市的一种申请，其申请程序及相关的法律责任对我国仿制药品申请管理制度的完善和发展有着借鉴意义。     

国内制药企业申报FDA制剂仿制药的调查与分析

目的为国内制药企业进行制剂仿制药FDA申报提供建议,促进我国制药企业的制剂国际化。方法通过对国内代表性的制药企业进行问卷和采访调查,并结合FDA仿制药申请的法规,分析影响国内制药企业申报美国制剂仿制药的主要因素。结果与结论提出促进我国制药企业申报FDA制剂仿制药的建议。     

ANDA申请中关于标签等包装标识物问题的探讨

目的：为我国药品制剂出口企业ANDA申请过程中有关标签等包装标识物资料申报和规范管理提出建议。方法：分析美国有关标签等包装标识物监管的法律、法规和指南的特征乖意图。结果和结论：我国药品制剂企业在ANDA申请工作中,标签等包装标识物部分存在问题,应对照美国的法律、法规进行修正。     

试论药品评价的方法及应用

目的：通过对药品评价的概念．开展的必要性、评价的方法以及应用等方面的阐述．探讨我国现阶段在药品评价方面所面临和要解决的问题。方法：参照《中国药品综合评价指南一参考大纲》及国外先进药品评价体制及方法．对我国的药品评价工作进行分析。结果：药品评价是涉及到医学．药学,流行病学、统计学及其他交叉学科基础知识的一项综合性很强的工作．在我国处于成长期。结论：开展好药品评价．能够促进新药的研发和临床的合理用药、减少卫生资源的浪费,最终达到保护公众健康和生命安全的目的。     

木丹颗粒新药咨询与药品生产企业药学服务

通过对本企业创新药物木丹颗粒用药咨询与药学服务的具体实施方略,分析目前所做工作取得的成绩和存在的不足。进而探究药品生产企业如何充分利用自身优势,在新药进入临床初期直接参与和提供药学服务,对该药物更快更好地发挥疗效、研究发现更多的适用范围、保障人民的用药安全发挥积极的作用。     

FDA “肽类药物产品临床药理学的考虑的供企业用的指导原则草案” 及其启示

美国食品药品管理局（FDA）于2023年9月发布了“肽类药物产品临床药理学的考虑的供企业用的指导原则草案”。该指导原则描述了FDA对肽类药物产品开发方案的临床药理学的建议,包括肝损害、药物-药物相互作用评估、心电图按心率校正的QT间期（QTc）延长风险评估以及免疫原性风险及其对药动学、安全性和有效性评估的影响。详细介绍FDA该指导原则的主要内容,期望对我国肽类药物产品临床药理学研究和监管有所启示。     

Considerations for Implementation of a New Drug Substance Container for Subzero Storage

Therapeutic manufacturing has become globalized in recent decades, necessitating transportation of drug substance across the world. The outcome of this expansion is significant costs for shipment and added risk of damage to the drug substance containers. There are multiple container options with various materials of construction for storage of Biologics drug substance (DS). This study evaluates a newly designed CryoVault? container and previously characterized CelsiusPak® bag container using a well-represented scale-down model. Consideration of an appropriate storage container includes the risk assessment of the design and material of construction, which can potentially impact product quality attributes, stability and container leachables. An extensive data package, including product stability over time and temperature with respect to impact of extractables and leachables from different containers undergoing a typical one freeze/thaw cycle process was evaluated. This drove to the decision for implementation of a container into the drug substance manufacturing process.     

浅谈制药企业在药品风险管理中的责任

目的探讨制药企业在药品风险管理中的责任。方法以预防-处理-反馈为主线,结合现状和具体案例,深入剖析制药企业在药品风险管理中应承担的责任。结论制药企业作为药品的供应者,不应只关心产品的销售和利润,还要关注企业与社会的协调发展,关注本企业研发生产的产品的安全性,在药品风险发生之前及时预防风险,在药品风险发生之后主动控制风险,降低损害程度,切实有效地保护消费者的生命安全。     

试论新时期的医院药事管理工作

目的重视医院药事管理工作,促进医院药学服务的发展。方法调查医院药事管理工作现状以及开展药事管理工作的新举措。结果与结论医院应加强政策法规的学习,提高对药事管理工作的认识,建立完善的药事管理制度,坚持＂以病人为中心,以质量为核心＂的管理模式,全面推进医院药事管理工作。     

1例万古霉素引起药物热的药学监护

目的探讨临床药师如何对化脓性心包积液患者开展药学监护。方法通过研究该患者所使用的抗感染用药,分析其可能的发热原因。结果万古霉素引起的药物热是该患者发热的主要原因。结论临床药师在临床实践中应关注万古霉素可能引起的药物热。     

Changes in the Solid State of Nicergoline,a Poorly Soluble Drug,Under Different Grinding and Environmental Conditions: Effect on Polymorphism and Dissolution

Nicergoline native crystals (Form I) were subjected to different grinding methods for 15, 30, 45, and 60 min: Method A, grinding at 20°C under air atmosphere; Method B, grinding in presence of liquid nitrogen under air atmosphere; Method C, grinding at 20°C under nitrogen atmosphere; and Method D, grinding in presence of liquid nitrogen under nitrogen atmosphere. Scanning electron microscopy, differential scanning calorimetry, X-ray powder diffractometry, thermogravimetry, and infrared spectroscopy were used to follow changes in the particle size and in crystalline structures. Batches from Methods A and C underwent partial amorphization immediately after grinding; Form II was obtained by heating these partially amorphous forms or after spontaneous crystallization after 1 and 5 months storage. Method B promoted the hydration of nicergoline to a monohydrate form. Batch D was stable under grinding and neither amorphization nor hydration were observed. The best intrinsic dissolution rate was that of metastable Form II, followed by Form I, while the worst was that of the Method B monohydrate form. The slowest particle dissolution was observed for hydrated particles, because of the lowest IDR, while the most rapid was exhibited by batch D, because of the very small particle size.     

Manufacturing classification system in the real world: factors influencing manufacturing process choices for filed commercial oral solid dosage formulations,case studies from industry and considerations for continuous processing

Abstract

Following the first Manufacturing Classification System (MCS) paper, the team conducted surveys to establish which active pharmaceutical ingredient (API) properties were important when selecting or modifying materials to enable an efficient and robust pharmaceutical manufacturing process. The most commonly identified factors were (1) API particle size: small particle sizes are known to increase risk of processing issues; (2) Drug loading in the formulation: high drug loadings allow less opportunity to mitigate poor API properties through the use of excipients. The next step was to establish linkages with process decisions by identifying publicly-available proxies for these important parameters: dose (in place of drug loading) and BCS class (in place of particle size). Poorly-soluble API were seen as more likely to have controlled (smaller) particle size than more highly soluble API. Analysis of 435 regulatory filings revealed that higher doses and more poorly-soluble API was associated with more complex processing routes. Replacing the proxy factors with the original parameters should give the opportunity to demonstrate stronger trends. This assumption was tested by accessing a dataset relating to commercial tablet products. This showed that, for dry processes, a larger particle size was associated with higher achievable drug loading as determined by percolation threshold.     

Introduction to Fourier Transform Infrared Spectroscopy and Applications in the Pharmaceutical Sciences

The applications of infrared spectroscopy to pharmaceutical sciences is small compared to the applications of infrared spectroscopy to the fields of chemistry, biology, and biochemistry. This is unfortunate because modern routine infrared spectrometers are excellent research tools that provide very high signal-to-noise, high resolution, and extensive data-manipulation computer software packages. This review summarizes basic principles of infrared spectrometers and the use of Fourier self-deconvolution.     

化学药品注册改革对我国医药行业的影响研究

摘 要国产仿制药注册在化学药品中占据较大比重,重复申报现象突出,企业低水平创新。在此背景下,化学药品注册改革拉起了序幕。而新药品注册分类的实施,上市许可人制度和药品注册申报资料的变化,对我国医药行业产生巨大的影响,促使国内医药市场重新洗牌,鼓励企业加大研发和创新力度,加快迈向国际的步伐。     

质量风险管理在药品固体制剂车间的应用

目的：降低在药品固体制剂车间多品种共线生产中的质量风险,确保产品质量。方法：根据药品固体制剂生产的主要操作工序大致相同的特点,运用质量风险管理的方法和工具,建立药品固体制剂车间的质量风险管理模型。结果与结论：通过对固体制剂车间多品种共用厂房、设施、设备生产中可能存在的风险进行评估,对风险高的环节采取有效的控制措施,使多品种共线生产所产生的质量风险降低到可以接受的水平,保证药品质量。     

展望2018：一个趋于理性的中国药物创新发展新时代

2017年是我国医药行业发展历史上浓墨重彩的一年,药物创新全面与国际接轨,新药创制“2.0版”拉开了序幕。上海市药物研发协同创新中心召开智库圆桌会议,通过多轮头脑风暴,浓缩顶尖专家智慧,坚持求实和前瞻性,对我国医药行业进行了具有重要参考价值的年度展望。

     

系统化处方评估联合药学干预促进医院合理用药的效果分析

目的 探讨系统化处方评估联合药学干预模式对医院合理用药的促进作用。方法 随机选择医院2012年门诊和住院处方各1200张,进行系统化处方评估,对出现的问题采取药学干预措施予以纠正。另随机选择2013年门诊和住院处方各1 200张,分析处方的合格率、不合格原因和药物用药频度、药物利用指数等指标。结果 系统化处方评估联合药师干预的模式开展后,2013年门诊处方及住院处方不合格数量均显著减少,分别为36张和28张,与2012年相比,差异有统计学意义（P〈0.05）;抗菌药物用药频度和药物利用指数下降最明显;绝大多数药品2013年药物利用指数均接近1,说明临床应用合理。结论 系统化处方评估联合药学干预可以提高医院处方质量,促进合理用药。     

解析制药企业药品不良反应监测意识缺失

通过分析我国制药企业药品不良反应监测意识缺失的原因,提出相应改进建议,旨在促进我国药品生产企业药品不良反应监测工作的开展。     

液质联用技术在药物分析中的应用研究进展

液相色谱-质谱联用技术以其高分离能力，高灵敏度，和专属性强的优势，在药物成分的鉴定分析、药物代谢研究、中成药和保健品中非法添加化学药物成分的鉴定分析以及药物残留分析等方面得到广泛的应用。本文简要综述了近年来液质联用技术在药物分析中的应用，为进一步扩大应用提供参考。     

论制药企业新产品研发立项评估

目的:为制药企业新产品研发立项评估提供参考。方法:根据笔者长期的工作经验并结合案例分析进行归纳与总结,详细阐述新产品研发立项评估的各个方面,包括医学价值、市场价值、技术可行性、投入产出等。结果与结论:新产品研发立项评估需要全面、详细、客观、准确地对新产品的医学价值、市场价值、技术可行性、投入产出等方面进行综合评估。