Good Laboratory Practice for Nonclinical Studies

图书简介

The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed.• Unique volume covering FDA inspections of GLP facilities• Provides a detailed interpretation of GLP Regulations• Presents the latest on electronic data management in GLP• Describes GLP and computer systems validation• Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements

Introduction - Willie Salminen 1. Subpart A - General Provisions – Graham Bunn i) Sec. 58.1 Scope ii) Sec. 58.3 Definitions. iii) Sec. 58.10 Applicability to studies performed under grants and contracts. iv) Sec. 58.15 Inspection of a testing facility. 2. Subpart B - Organization and Personnel - Denis Roy, Bettina Donato i) Sec. 58.29 Personnel. ii) Sec. 58.31 Testing facility management. iii) Sec. 58.33 Study director iv) Sec. 58.35 Quality assurance unit. 3. Subpart C – Facilities - Willie Salminen i) Sec. 58.41 General. ii) Sec. 58.43 Animal care facilities. iii) Sec. 58.45 Animal supply facilities. iv) Sec. 58.47 Facilities for handling test and control articles. v) Sec. 58.49 Laboratory operation areas vi) Sec. 58.51 Specimen and data storage facilities 4. Subpart D – Equipment – Graham Bunn i) Sec. 58.61 Equipment design. ii) Sec. 58.63 Maintenance and calibration of equipment. 5. Subpart E - Testing Facilities Operation - Willie Salminen i) Sec. 58.81 Standard operating procedures. ii) Sec. 58.83 Reagents and solutions. iii) Sec. 58.90 Animal care. 6. Subpart F - Test and Control Articles - Denis Roy, Bettina Donato i) Sec. 58.107 Test and control article handling. ii) Sec. 58.113 Mixtures of articles with carriers. 7. Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study - Jeff Ambroso i) Sec. 58.120 Protocol. ii) Sec. 58.130 Conduct of a nonclinical laboratory study. 8. Subpart J - Records and Reports - Jennifer Roberts i) Sec. 58.185 Reporting of nonclinical laboratory study results. ii) Sec. 58.190 Storage and retri

Trade Policy 买家须知

关于产品：
● 正版保障：本网站隶属于中国国际图书贸易集团公司，确保所有图书都是100%正版。
● 环保纸张：进口图书大多使用的都是环保轻型张，颜色偏黄，重量比较轻。
● 毛边版：即书翻页的地方，故意做成了参差不齐的样子，一般为精装版，更具收藏价值。
关于退换货：
由于预订产品的特殊性，采购订单正式发订后，买方不得无故取消全部或部分产品的订购。
由于进口图书的特殊性，发生以下情况的，请直接拒收货物，由快递返回：
● 外包装破损/发错货/少发货/图书外观破损/图书配件不全（例如：光盘等）
并请在工作日通过电话400-008-1110联系我们。
签收后，如发生以下情况，请在签收后的5个工作日内联系客服办理退换货：
● 缺页/错页/错印/脱线
关于发货时间：
一般情况下：
●【现货】下单后48小时内由北京（库房）发出快递。
●【预订】【预售】下单后国外发货，到货时间预计5-8周左右，店铺默认中通快递，如需顺丰快递邮费到付。
● 需要开具发票的客户，发货时间可能在上述基础上再延后1-2个工作日（紧急发票需求，请联系010-68433105/3213）；
● 如遇其他特殊原因，对发货时间有影响的，我们会第一时间在网站公告，敬请留意。
关于到货时间：
由于进口图书入境入库后，都是委托第三方快递发货，所以我们只能保证在规定时间内发出，但无法为您保证确切的到货时间。
● 主要城市一般2-4天
● 偏远地区一般4-7天
关于接听咨询电话的时间：
010-68433105/3213正常接听咨询电话的时间为：周一至周五上午8：30～下午5：00，周六、日及法定节假日休息，将无法接听来电，敬请谅解。
其它时间您也可以通过邮件联系我们：customer@readgo.cn,工作日会优先处理。
关于快递：
● 已付款订单：主要由中通、宅急送负责派送，订单进度查询请拨打010-68433105/3213。

Good Laboratory Practice for Nonclinical Studies（Drugs and the Pharmaceutical Sciences） 食品及药物管理局良好实验室规范要求 药物化学

Good Laboratory Practice for Nonclinical Studies（Drugs and the Pharmaceutical Sciences）

食品及药物管理局良好实验室规范要求
药物化学