BBR试验指南
阿尔茨海默病治疗药物临床研究技术指导原则
指导原则编号:【】治疗阿尔茨海默病药物临床试验技术指导原则（第二稿）二○○七年三月目录一、概述 (3)二、有效性和安全性评价要点 (5)（一）适应症定位 (5)（二）受试人群 (5)（三）有效性评价 (8)（四）安全性评价 (10)（五）临床试验的质量控制 (11)三、分期试验设计 (11)（一）Ⅰ期临床试验： (11)（二）Ⅱ期临床试验 (13)（三）Ⅲ期临床试验 (15)四、预防和控制疾病进展药物的临床试验 (16)（一）轻度认知功能损害（MCI）者的临床试验 (16)（二）控制疾病进展药物的临床试验 (17)五、缩略语 (17)六、参考文献 (19)七、著者 (20)治疗阿尔茨海默病药物临床试验技术指导原则一、概述痴呆是一种以认知功能缺损为核心症状的获得性临床综合征，如进行性记忆、思维、语言、行为和人格障碍等，可伴随精神和运动功能障碍，其认知损害的程度足以影响日常生活、社交或职业功能或与个人以前相比有显著下降。
痴呆的病因很多，病理生理过程复杂，其中常见的为阿尔茨海默病（AD）、血管性痴呆（VaD）和混合性痴呆。
阿尔茨海默病是一组病因未明的原发性退行性脑变性疾病。
多起病于老年期，病程缓慢且不可逆，临床上以智能损害为主，是老年常见病之一。
虽然目前尚无“抗痴呆”药物可以治愈此病，但是已有多种对症治疗药物用于临床，一些新的药物也处于研发阶段。
药物临床试验是药物研发中的一个重要环节，是一个目的性和逻辑性极强，并渐次推进的探索循证过程。
内容主要包括人体耐受性、药代动力学、药物相互作用、人体药效学、剂量效应探索、疗效确证研究等，按照试验的时间进程又可以分为Ⅰ、Ⅱ、Ⅲ、Ⅳ期等几个阶段。
在试验进程中，每项试验均有其特定的目的和研究方法，同时各项试验之间又有着紧密的联系。
早期小规模试验的信息用于支持规模更大、目的性更强的后续试验，不同时期或同一时期进行的各项临床试验的信息互为补充，共同构成药物的安全有效性基础。
治疗阿尔茨海默病药物临床试验技术指导
指导原则编号: 【】治疗阿尔茨海默病药物临床试验技术指导原则（第二稿）二○○七年三月目录一、概述............................................................................. ........................ 3 二、有效性和安全性评价要点. (5)（一）适应症定位 (5)（二）受试人群 (5)（三）有效性评价 (8)（四）安全性评价 (10)（五）临床试验的质量控制............................................................ 11 三、分期试验设计 .................................................................................. 11 （一）Ⅰ期临床试验： .................................................................... 11 （二）Ⅱ期临床试验........................................................................ 13 （三）Ⅲ期临床试验........................................................................ 15 四、预防和控制疾病进展药物的临床试验 .......................................... 16 （一）轻度认知功能损害（MCI）者的临床试验 ................................ 16 （二）控制疾病进展药物的临床试验..................................................17 五、缩略语 ............................................................................ .................. 17 六、参考文献 ............................................................................ .............. 19 七、著者 ............................................................................ ...................... 20 2治疗阿尔茨海默病药物临床试验技术指导原则一、概述痴呆是一种以认知功能缺损为核心症状的获得性临床综合征，如进行性记忆、思维、语言、行为和人格障碍等，可伴随精神和运动功能障碍，其认知损害的程度足以影响日常生活、社交或职业功能或与个人以前相比有显著下降。
双胎反向动脉灌注序列征诊治及保健指南(2020完整版)
双胎反向动脉灌注序列征诊治及保健指南（2020完整版）本指南中循证医学证据等级标准：1+：管理完善的M eta分析、随机对照试验的系统回顾或偏倚风险低的随机对照试验；2++：高质量的病例对照或队列研究的系统回顾；高质量的混杂偏倚风险极低的病例对照研究或队列研究，且具有高度可能性的因果关系；2+：管理完善的混杂偏倚风险低的病例对照研究或队列研究，且具有中等可能性的因果关系；2-：混杂偏倚风险高的病例对照研究或队列研究，且具有高度不明确的因果关系的风险；3：非分析研究，如病例报道、病例分析。
推荐等级分类标准：A：至少一项证据等级1++的Meta分析、系统回顾或随机对照试验，直接针对目标人群，或主要由证据等级1+的研究构成的系列证据，直接针对目标人群并证明结果一致；B：证据等级2++的系列研究证据，直接针对目标人群并证明结果一致，或根据证据等级1++或1+研究推断的证据；C：证据等级2+的系列研究证据，直接针对目标人群并证明结果一致，或根据证据等级2++研究推断的证据；D：证据等级3级或4级，或根据证据等级2+研究推断的证据。
良好的实践参考：基于指南制定小组专家的临床经验和观点，推荐的最佳临床实践。
本指南循证医学证据等级和推荐等级标准参考英国皇家妇产科医师学会（RCOG）和国际妇产超声学会（ISUOG）相关指南。
双胎反向动脉灌注序列征（twinreversed arterial perfusion sequence，TRAPs）或称无心胎（Acardiac twinning），是双胎妊娠中复杂性双胎主要的胎儿并发症之一。
其表现为双胎之一发育失去正常形态且无胎心搏动。
未经过治疗的TRAPs中，发育正常胎儿的死亡率可高达50%~70%，而随着各种治疗手段的出现，其死亡率可下降到10%~20%。
近年来，随着我国胎儿医学的发展，产前筛查和诊断技术以及胎儿治疗和围产保健水平的不断提高，面临着如何指导和规范复杂性双胎的临床诊治和保健工作，为此，中国妇幼保健协会双胎妊娠专业委员会结合国内外研究进展和学科研究成果及调研情况特制定了本指南，旨在降低围产儿的死亡率和伤残率，提高胎儿的存活率和生命质量。
0903 BBR试验指南-陈礼奔
一、开机
1：打开气源，调节LINE压力为40psi, AIR BEARING为25psi
2：打开主机电源，打开控制台（电脑），如 下图，选择BBRW软件，双击打开
二、仪器参数设定
若软件重新安装，第一次打开后会出现下 图提示框，提示需要输入的仪器参数，如 果不是第一次打开软件则不会出现提示框， 该步骤可以略过，但仍然可以在SETUP菜 单中点击INSTRUMENT SETUP进入仪器 参数设定或查看
7: 按照提示将主机控制模式改成 REMOTE, 点击确定
8: 提示放入试样，放入后确定
开始试验
9: 试验结束后自动显示试验报告
提示: 试验数据可以在设定的文件夹 内找到
本文仅供公司内部或特定客户使用 版权所有，翻录不究 BY CLB
b: 在加载梁上放100克砝码，稳定后 点NEXT
c: 再放入2个100克砝码使得总重为 300克，NEXT
d: 上一步结束后出现下图菜单，提 示移除所有砝码和薄梁
e: 结束测试，出现下图标定结果
3：温度标定
a: 在SETUP菜单中选择仪器参数设定，输入目标温 度
b: 打开温度控制
c: 待温度稳定至设置的温度后，在 标定菜单中选择第二项标定
7：CONFIDENCE TEST 校验测试上下限值设定，参考标定证书中数 值
三、标定
点击CALIBRATION菜单选择标定项目，或， 若第一次打开软件，在设定完参数后会自 动出现标定提示框开始标定
1：力和位移标定
a: 按照提示在主机中设定控制模式和加载模式为 LOCAL和ZERO，移除水浴中的梁（如果有）
b: 放高度标定块（TOP端），并在轴承梁上加100克砝码， 稳定后点击NEXT; 接着依照提示将TOP端换成红、白、蓝颜 色标记的高度端，然后继续下一步
沥青混合料动态模量的测定及其应用
沥青混合料动态模量的测定及其应用【摘要】沥青混凝土模量是沥青路面结构设计中的重要参数，而动态模量(复数模量|E*|)由于更接近于路面工作状态而受到关注。
但由于沥青混合料具有复杂的粘弹特性，导致国内外对于动态模量的测定持有不同观点。
通过对沥青混合料的动态模量测定的叙述，结合前人的研究成果，讨论将此模量运用到实际工程领域中的方法。
【关键词】动态模量；粘弹特性；实践应用【abstract 】the asphalt concrete modulus is the asphalt pavement structure design of the important parameters, and the dynamic modulus (amount of complex modulus | E * |) with more close to pavement working state and attention. But because the asphalt mixture have complex viscoelastic properties, both at home and abroad for dynamic modulus to the determination of the hold different opinions. Through to the asphalt mixture of dynamic modulus determination of the narrative, combining with the results of other researchers, the discussion will be the modulus applied to practical engineering method in the field of.【key words 】dynamic modulus; The viscoelastic properties; practice对于沥青路面材料设计，沥青混合料的模量是沥青路面设计的最主要参数，随着国内外相关部门对沥青材料路用性能研究的深入，大多数专家均认为沥青混合料的动态模量更能反映其受力特征。
Silicon Labs Z-Wave 认证测试准备指南说明书
Document No.:INS14284Version:2Description:-Written By:AMUNKHAUSDate:2019-02-17Reviewed By:JFR;MHANSEN;NOBRIOT;JOPEDERSEN;BBR;JCC;SCBROWNI Restrictions:PublicThis document is the property of Silicon Labs. The data contained herein, in whole or in part, may not be duplicated, used or disclosed outside the recipient for any purpose. This restriction does not limit the recipient's right to use information contained in the data if itis obtained from another source without restriction.INS14284-2Prepare for Z-Wave Certification Tests2019-02-17INS14284-2Prepare for Z-Wave Certification Tests2019-02-17Table of Contents1ABBREVIATIONS (4)2INTRODUCTION (5)2.1Purpose (5)2.2Audience and Prerequisites (5)3Z-WAVE IS INTEROPERABILITY (6)4Z-WAVE CERTIFICATION (7)4.1Certification Process Overview (7)4.2Z-Wave 700 Hardware (8)4.2.1QFN Certification (8)4.3Z-Wave Plus v2 Certification (9)4.4Z-Wave Alliance: Market Certification (10)5QUESTIONS ON CERTIFICATION? (11)REFERENCES (12)Table of FiguresFigure 1: Contact the Z-Wave Certification Manager (11)INS14284-2Prepare for Z-Wave Certification Tests2019-02-17 1ABBREVIATIONSINS14284-2Prepare for Z-Wave Certification Tests2019-02-17 2INTRODUCTION2.1PurposeThe purpose of this document is to give an overview of the Z-Wave Certification process for the Z-Wave 700 products.The document is created with the intention to keep it short while describing both benefits of the certification program and highlight the steps in the process of certifying a product.This document will also serve as a guide in where to find additional information.2.2Audience and PrerequisitesThe audience is Z-Wave partners and OEM integrators. The document can be used by stakeholders to explain the benefits of the Z-Wave ecosystems as well as developers to guide them in completing the certification.INS14284-2Prepare for Z-Wave Certification Tests2019-02-17 3Z-WAVE IS INTEROPERABILITYMany people understand different things for the word ‘Interoperability’. Interoperability is not just having various nodes joining one network. A Wi-Fi thermostat and printer may operate on the same home network, but they don’t talk to each other. When a consumer leaves his or her home, they want to push one button that will lock all doors, arm the alarm system, set the temperature, and switch off all the lights. The products are likely from different vendors, so just having them join the same network is not interoperability. They all need to speak the exact same language. This is called Application Layer Interoperability.Z-Wave requires application interoperability in all products and has put in place a stringent certification program that all products go through to ensure correct commands are being used in products.Each product must follow the Z-Wave Plus v2 specification to be able to pass the certification program and ensure interoperability in the ecosystem of existing products. The primary focus is ease of use for consumers, which can be summarized into:∙Shopping does not require intensive knowledge about which products work with other products.∙Installation is as simple as possible and intuitive.∙Operating the products does not require any technical knowledge.∙No tricky maintenance procedures such as exclude/include.The certification program is executed by independent certification laboratories, and the process is simple:1)Join the Z-Wave Alliance2)Download the Self-Certification Tool on 3)Access and fill out the online form and documentation4)Submit the product to the third-party test house5)Once the product passes certification and product and packaging labels are approved, the Z-Wave Cert Logo is awarded, and the product can go to the market.These steps are further described in a later section.Consumers and channel partners will recognize that the product is Z-Wave certified and will work seamlessly with other Z-Wave products. Z-Wave gives the freedom to choose devices from different vendors giving end users a choice and enabling manufacturers to leverage the ecosystem of devices.Z-Wave is interoperability.INS14284-2Prepare for Z-Wave Certification Tests2019-02-17 4Z-WAVE CERTIFICATIONInteroperability between all Z-Wave products is the cornerstone of the brand. To make this brand promise to developers, customers, and consumers, there is a straight-forward certification program in place. All Z-Wave products must be certified before commercial launch. When the certification requirements have been met, products can feature the Z-Wave interoperability logo badges.4.1Certification Process OverviewBecause the product must meet specific certification requirements, consider the technical requirements for your device early in the process.Scope the technical requirements prior to starting the development process as it is easier to ensure that the device will meet the requirements to pass certification if they have been incorporated from the beginning. A tip is to use the certification form as a guideline.Use the resources available to your disposal to work as efficient as possible. For example, the Compliance Test Tool (CTT) [11] and Wiki test specification pages [6].The certification process is simple, just follow these steps:1.Create a Silicon Labs user account to get access to the Z-Wave technical site where all thespecifications for certification [1] are available.2.Request access to the web-based Z-Wave Plus Certification Portal [5] and start a devicesubmission to help identify all the certification requirements.3.The company whose brand will appear on the product MUST join the Z-Wave Alliance as a fullmember, as this is a requirement for market certification. Consider this step early in yourdevelopment process, to take advantage of benefits the Alliance provides that can speed your time to market. Login to the Z-Wave Alliance member website [10] to review the latest Market Certification requirements and guidelines.4.Hardware specific (see “4.2 Z-Wave 700 Hardware”): If your product is using a SoC module youmust also achieve QFN Certification before you can finalize your certification form. For moreinformation, refer to 4.2.1.5.Download the Compliance Test Tool [11] tool and use it during product development to testand verify your Z-Wave implementation and that all mandatory device and command classrequirements have been implemented properly.6.After ensuring a compliant product, finalize and submit your form on the portal. A case numberis automatically assigned as soon as it is submitted. You can start working with the test house as soon as your submission has been reviewed and approved. For more information, refer to 4.3.INS14284-2Prepare for Z-Wave Certification Tests2019-02-177.Start your Market Certification on the Z-Wave Alliance’s website as soon as you have a casenumber. For more information, refer to 4.4.8.Device certifications are issued after the device has passed the technical tests AND the MarketCertification has been approved by the Alliance.9.After approval, launch your product into the interoperable Z-Wave ecosystem, which enjoysover 70% market share in the smart home. The Z-Wave brand guidelines can be found here[12].4.2Z-Wave 700 HardwareThe certification process is slightly different depending on which Z-Wave 700 product you are developing. It is therefore important to understand the main differences of the Z-Wave 700 hardware. The Z-Wave 700 series consist of two hardware components:∙Z-Wave 700 EFR32ZG14 SoC ModuleThis modem SoC part is suitable for Z-Wave gateways only and cannot be used for end-devices.The EFR32ZG14 consists of a simple serial port to communicate with the host controller, and a sub-GHz radio for RF communications to Z-Wave end devices. The Z-Wave protocol stack is fully implemented on chip, and a simple serial API is used for data and control.∙Z-Wave ZGM130S SiP ModuleThis general-purpose module combines a SoC with a built-in microcontroller and RF transceiver, crystal, & passive RF components into one SiP module. It is mainly used for end-devices but can also be used for controllers.4.2.1QFN CertificationQFN Certification is used for certifying products where the SoC module is used in the design. This means designs using the SiP module do not have to go through QFN Certification. As such, an end-device do not need to pass the QFN Certification as end-devices can only be based on a SiP module. Only controllers based on a SoC module must pass this certification.A QFN Certification involves comprehensive RF testing. This testing is conducted at Silicon Labs’ facilities in Singapore and fees are paid to Silicon Labs.The device must achieve QFN Certification before it is submitted for Z-Wave Plus v2 certification.Fill out the QFN Certification Form [8] and contact the SiLabs Certification Manager to start the certification.INS14284-2Prepare for Z-Wave Certification Tests2019-02-17 4.3Z-Wave Plus v2 CertificationZ-Wave Plus certifications include stringent technical compliance testing and is carried out using the Z-Wave Plus Certification Portal. The forms in the portal should also be used during the definition stage of product development. Cases can be saved for completion at a later date, so it is easy to get started even if you don't have all the details.Use the integrated Wiki to see the test specifications for your device. Question Mark icons “” are located throughout the certification form. Clicking on these icons opens a Wiki page with more information and in many cases, the related test specification.Certification cases are identified as being in one of the following phases:1.Initial Form Selection – Developer identifies and selects what is being implemented.2.Self-Certification – Developer conducts self-certification tests and verifies compliance.3.Initial Review – Case has been submitted by the developer and is pending initial review.4.Wait for Verification Test – Case has passed initial review and developer needs to pay the feesand submit required documentation and test samples to the selected test partner.5.Verification Test – Test Partner has received everything (all required documentation, testsamples and fees) and the device is ready to be tested. At the completion of testing, results will be submitted to the Certification Manager for review and processing.6.Wait for Ad Hoc Test – Initial testing resulted in minor issues and the developer needs tosubmit fixes to the test partner. (Ad Hoc is a 30-day period during which the developer worksdirectly with the test partner to resolve all issues.)7.Ad Hoc Test – The test partner has received everything needed to re-test the device and verifythe issues have been resolved. At the completion of testing, results will be submitted to theCertification Manager for review and processing.8.Market Certification – A case may be in this phase for either of the following reasons:a.This is a review-only recertification that has passed the initial review. It will remain inthis phase until the Z-Wave Alliance has approved the Market Certification for thisdevice.b.The test results for this case have been received from the test partner; however, theMarket Certification for this device has not yet been approved by the Z-Wave Alliance.A device certification cannot be issued until the Market Certification has been approvedso this case will remain in this phase until that has been accomplished.9.Certification Finished – The certification case has been closed. Possible outcomes are:a.Passed and certification issued.b.Failed - Device must be resubmitted as a new case.c.Cancelledd.Expired – Developer has exceeded the allowed time for ad hoc issue resolution.e.RevokedRefer to the Z-Wave Certification Portal Getting Started Guide [6] for more information.INS14284-2Prepare for Z-Wave Certification Tests2019-02-17 4.4Z-Wave Alliance: Market CertificationThe Z-Wave Alliance consists of over 700 companies and over 2400 products, all interoperable with each other.Market Certification ensures that your product carries the proper logo and certification marks. Market certification is mandatory for all Z-Wave Plus products and is administered by the Z-Wave Alliance. Market Certification verifies:1.The placement and size of the Z-Wave Plus mark on your product and product packaging.2.The placement, size, method, and material for the Z-Wave Security 2 Device Specific Keyinformation on your product.3.That the common and key information is present in the user guide/manual for your product.4.That the image, description, and features of the product are accurate and helpful to consumers. Start your Market Certification on the Z-Wave Alliance’s website [10] as soon as you have a case number.INS14284-2Prepare for Z-Wave Certification Tests2019-02-17 5QUESTIONS ON CERTIFICATION?To get access to the online Certification Portal or if you have any questions regarding certification, reach out to the Certification Manager.Create a new case on and make sure to select “Z-Wave Certification-Wireless-“ as the part number.Figure 1: Contact the Z-Wave Certification ManagerINS14284-2Prepare for Z-Wave Certification Tests2019-02-17 REFERENCESThis section will summarize and link to important information to give the complete overview.[1]Z-Wave SpecificationSpecification documents.[2]Get Certified with Z-WaveA short overview of the certification process similar to this document.[3]Z-Wave Plus Certification ProgramA short overview of Z-Wave Plus Certification similar to this document.[4]INS10638 – Z-Wave Certification OverviewDocument describing the entire Z-Wave Certification in a much greater detail than this document.[5]Z-Wave Certification PortalThe Z-Wave Certification Portal is where you submit your device for certification.[6]Z-Wave Certification Portal: Wiki Getting StartedA walkthrough guide for how to fill in the Certification Form.[7]Z-Wave Certification Portal: Wiki Test OverviewAn overview of all the test cases.[8]INS12202 - Z-Wave QFN Certification FormThe certification form needed for QFN Certification.[9]INS12578 - Z-Wave Certification Fee ScheduleOverview of fees applied to Z-Wave Certification.[10]Z-Wave AllianceHome of the Z-Wave Alliance.[11]Z-Wave Compliance Test Tool (CTT)A tool to assist in performing the self-certification tests required for verification that CommandClasses (CCs) have been implemented correctly.[12]Z-Wave Brand GuidelinesLogo usage and brand guidelines.。
M320-03 沥青胶结料性能分级标准规范
3
性能等级 10 平均 7d 最高路面设计温度 a， （ ℃） 最低路面设计温度 a，（℃） 闪点温度，T48：最小（℃） 黏度，T316：b 最大，3Pa•s，试验温度， （℃） 动态剪切，T315：c G*/sinδd，最小，1.00kPa 试验温度@10rad/s，（℃） >-10 >-16 16 22
M320-03 沥青胶结料性能分级标准规范
1 适用范围
本规范适用于沥青胶结料性能分级，分级与平均 7d 路面最高设计温度和路面最低设计温度有关。 注 1.――黏稠沥青以 25℃针入度分级，见《沥青胶结料针入度分级规范》 （M20） ；黏稠沥青以 60 ℃黏度分级，见《沥青胶结料黏度分级规范》 （M226） 。 注 2.――《沥青胶结料性能的分级和验证》 （R29）指南提供了关于沥青胶结料性能分级的测定方 法的资料。
PG70 28 <70 >-22 >-28 >-34 >-40 >-10 >-16 34 40 10 16
PG76 22 28 <76 >-22 >-28 >-34 >-10 >-16 原样胶结料 34 10 16
PG82 22 <82 >-22 >-28 >-34 28 34
70 旋转薄膜烘箱残留物（T240）
6
6 取样
按 T40 方法进行材料取样。
7 试验方法
在 5.3、5.4 和 5.6 中列出的性质要根据下列试验方法确定： R28、T44 或 ASTM D5546、T48、T55、T240、 T313、T314、T315 和 T316。
8 监理和认证
材料的监理和认证应符合采购者和销售者之间的协议，销售商应给采购商提供认证的沥青胶结料 等级的材料处治和贮存方法，特别要求将此作为采购合同的一部分。
IND和BA_BE研究的安全性报告要求
行业和研究者指导原则IND和BA/BE研究的安全性报告要求美国公共与卫生服务部食品药品监督管理局药品评价与研究中心（CDER）生物制品评价与研究中心（CBER）2012年12月药品安全行业和研究者指导原则IND和BA/BE研究的安全性报告要求从下面可以获得额外副本：药品信息部，通信办公室，WO51，2201室10903 New Hampshire Ave.Silver Spring，MD 20993-0002电话：301-796-3400；传真：301-847-8714druginfo@/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm或食品药品监督管理局生物制品评价与研究中心通信、外联与发展办公室，HFM-401401 Rockville Pike，Suite 200N，Rockville，MD 20852-1448ocod@；电话： 800-835-4709 或301-827-1800/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm美国卫生与公共服务部食品药品监督管理局药品评价与研究中心（CDER）生物制品评价与研究中心（CBER）2012年12月药品安全目录Ⅰ．简介 (1)Ⅱ．背景和要求的简要概述 (1)A. IND安全性报告要求 (2)B.对于BA和BE研究的安全性报告要求（21 CFR 320.31（d）（3）） (3)Ⅲ．定义（21 CFR 312.32（a）） (3)A．不良事件（21 CFR 312.32（a）） (3)B. 可疑不良反应（21 CFR 312.32（a）） (4)C. 不良反应5 (5)D. 非预期的（21 CFR 312.32（a）） (5)E. 严重的（21 CFR 312.32（a）） (6)F. 危及生命的（21 CFR 312.32（a）） (7)Ⅳ．安全性信息的审查（21 CFR 312.32（a）） (7)Ⅴ．监控安全性数据库和提交IND安全报告 (7)A. 严重和非预期的可疑不良反应（21 CFR 312.32（c）（1）（i）） (8)B. 其它来源的发现（21 CFR 312.32（c）（1）（ii）和（iii）） (13)C. 严重可疑不良反应发生增多（21 CFR 312.32（c）（1）（iv）） (14)Ⅵ. 其它安全性报告问题 (14)A. 可替代的报告准备（21 CFR 312.32（c）（3）） (14)B. 研究者手册 (15)C. 揭盲 (16)D. 研究者报告（21 CFR 312.64（b）） (17)E. 上市药物的调查研究（21 CFR 312.32（c）（4）） (19)F. 向伦理委员会（IRB）报告不良反应 (20)G. 安全性报告期间 (20)H. IND年度报告和标识 (21)Ⅶ. 提交IND安全性报告（21 CFR 312.32（c）（1）（v）） (21)A. 报告识别和格式 (21)B. 提交到哪里或如何提交 (23)C. 报告的时间框架 (23)Ⅷ.后续信息（21 CFR 312.32（d）） (24)Ⅸ. 对于BA和BE研究的安全性报告要求 (25)A. BA/BE研究安全性报告要求（21 CFR 320.31（d）（3）） (25)B. 在非-美国地区进行的BA/BE研究 (26)C. 如何和在哪提交报告（21 CFR 320.31（d）（3）） (26)Ⅹ. 参考文献 (28)附录A：不良反应领域 (29)附录B：研究者和申办者的报告责任 (30)行业和研究者指导原则1IND和BA/BE研究的安全性报告要求本指导原则即代表食品药品管理局（FDA）关于这一主题的最新见解。
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7: 按照提示将主机控制模式改成 REMOTE, 点击确定
8: 提示放入试样，放入后确定
开始试验
9: 试验结束后自动显示试验报告
提示: 试验数据可以在设定的文件夹 内找到
本文仅供公司内部或特定客户使用 版权所有，翻录不究
BY CLB
1：BATH 水浴温度设定,在对话框中输入目标温度，但要使设定起作用 需开启温度控制，该功能在SETUP菜单中，点击ENABLE TEMPERATURE CONTROL即可。
2：EQUIPMENT 输入设备序列号，温度传感器序列号及常数系数 A0,A1,A2, 以上数值在标定证书中查询
3：GAGE BLOCK 输入高度标定块四个点的高度，数值在标定证书中
d: 在出现的对话框中输入高精度温度计读取的水浴 温度，然后点击OK结束标定；其他温度点的标定步 骤相同
四、测试
1：在水浴中放入厚梁，在LOCAL状态下选 择ZERO，然后调节ZERO压力调节阀并观察 软件菜单中的FORCE项，调至35正负10mN
2: 将ZERO拨至LOAD，调节LOAD 压力到980正负50mN
BBR试验指南
一、开机
1：打开气源，调节LINE压力为40psi, AIR BEARING为25psi
2：打开主机电源，打开控制台（电脑），如 下图，选择BBRW软件，双击打开
二、仪器参数设定
若软件重新安装，第一次打开后会出现下 图提示框，提示需要输入的仪器参数，如 果不是第一次打开软件则不会出现提示框， 该步骤可以略过，但仍然可以在SETUP菜 单中点击INSTRUMENT SETUP进入仪器 参数设定或查看
b: 放高度标定块（TOP端），并在轴承梁上加100克砝码， 稳定后点击NEXT; 接着依照提示将TOP端换成红、白、蓝颜 色标记的高度端，然后继续下一步
放置高度标定块和砝码示意图 （TOP端）
c: 移除砝码和高度标定块，放入厚 梁
水浴放置厚梁示意图
d: பைடு நூலகம்节ZERO压力，直到加载架刚 好接触到梁
查询
4：ARCHIVE 设定数据存储文件夹，默认为C:\, 如需自行指定则在指定路 径中先建立文件夹（比如BBRDATA为名称的文件夹），然 后点击BROWSE选择即可。
5：PORT 设定通讯端口，默认为COM1, 如果使用了其他端口 则需要在此选中该端口
6：BEAM DIMMENSIONS 输入薄梁厚度、宽度，厚梁厚度，数值在标定证书 中查找
7：CONFIDENCE TEST 校验测试上下限值设定，参考标定证书中数 值
三、标定
点击CALIBRATION菜单选择标定项目，或， 若第一次打开软件，在设定完参数后会自 动出现标定提示框开始标定
1：力和位移标定
a: 按照提示在主机中设定控制模式和加载模式为 LOCAL和ZERO，移除水浴中的梁（如果有）
b: 在加载梁上放100克砝码，稳定后 点NEXT
c: 再放入2个100克砝码使得总重为 300克，NEXT
d: 上一步结束后出现下图菜单，提 示移除所有砝码和薄梁
e: 结束测试，出现下图标定结果
3：温度标定
a: 在SETUP菜单中选择仪器参数设定，输入目标温 度
b: 打开温度控制
c: 待温度稳定至设置的温度后，在 标定菜单中选择第二项标定
e: 在加载架梁上放100克砝码，下一步，然后按照 提示逐步加砝码，每次加一个100克，直到最后一 步的400克总重
f: 完成上述步骤后移除所有砝码，然 后移走厚梁
g: 上一步结束后点击下一步即完成 该项标定，出现标定结果如下图
2：加载校验测试
a: 标定完成后自动出现下图菜单, 按照提示设置主 机模式为LOCAL和ZERO, 在水浴中放入薄梁
3: 选择TEST菜单中的RUN A NEW TEST开始新的测试
4: 在提示框中输入浸浴时间，试样名称，文 件名称，项目名，操作者等信息
5: 如果目标温度（即测试温度）未经过标定，则出现以下对 话框，选择确定继续试验或选择取消退出试验进行温度标定， 若目标温度经过标定不会出现下图对话框
6: 如果当前温度未稳定在目标温度正负0.1度，则出现下图 对话框，选择确定继续或选择取消退出，等待温度稳定后再 做试验，如果温度在要求范围内开始试验不会出现下图对话 框