这是有关临床试验文件的第二部分。美国 FDA 对于所有美国 IND 试验要求有 1572 表 格。FDA 要求每个研究者均填写和签署 1572 表。这也是主要研究者和美国 FDA 间有法定 约束力的协议。如果 1572 表有所改动，应该再次提交给申办者，以便再次递交 FDA。1572 表包括研究者对 FDA 的承诺。点击 LIBRARY 可以从这个网址上下载该表格的样本

The expressed purpose of the Pesticide Analytical Manual is to publish analytical methodology used by the FDA in enforcing pesticide tolerances. To understand FDA’s application of methodology published in the manual, it is important to

Pesticide Analytical Manual Vol. I Transmittal No. 2000-1 (10/1999) Form FDA 2905a (6/92) PESTICIDE ANALYTICAL MANUAL VOLUME I 3rd Edition, 1994 Revised, September, 1996 Revised, October, 1997 Revised, October 1999 EDITORIAL STAFF

Transmittal No. 96-E1 (9/96) Form FDA 2905a (6/92) INDEX: METHODS–1 Pesticide Analytical Manual Vol. I INDEX: METHODS Index to PAM I Methods, by Chemicals Tested for Recovery Codes: C: complete (recovery); P: partial; S: small; V: variable; R: recovered; NR: not recovered

10.1 Federal Regulation of Medical Devices 10.1.1 The Law (including amendments) 10.1.2 Organization of FDA 10.1.3 Classification of Devices 10.1.4 Process of Assessment 10.1.4.1 510(k)Substantial Equivalence 10.1.4.2 Premarket Approval 10.1.5 Clinical Trials (Investigational Device Exemption) 10.1.6 Labeling 10.1.7 Tripartite Biocompatibility Guidance 10.1.8 Standards 10.1.9 Good Manufacturing Procedures 10.1.10 Good Laboratory Practices 10.2 Clinical Trial Design

Caution: Use this table only as a quick reference for tentative identification of residues found in samples analyzed by the most com￾monly used PAM I multiresidue methods. Always compare the residue to a standard chromatographed in your own gas chromatograph

Recovery of Chemicals Through Method 401 (E1-E2 + C1 + DL1) (methanol extraction, cleanup with partitioning and charcoal/Celite column, HPLC with post-column derivatization and fluorescence detection)

Pesticide multiresidue methods (MRMs) are capable of simultaneously determin￾ing more than one residue in a single analysis; this multiresidue capability is provided by a GLC or HPLC determinative step that separates residues from one another before detection. The MRM concept is raised to a higher dimension when a single extract is examined with more than one chromatographic determinative

一、美国食品和药物管理署的历史 美国食品和药物管理署(Food and Drug Administration，FDA)是一个由医生、律师、 微生物学家、药理学家、化学家和统计学家 等专业人士组成的政府卫生管制和监控机构， 该机构致力于保护、促进和提升美国国民的 卫生和健康

·药事管理 卫计委发布《加强药事管理转变药学服务模式的通知》 药物临床试验报告造假可判 5 年 ·治疗指南 格列喹酮临床应用专家共识（2017 年版） 糖皮质激素在疼痛微创介入治疗中的应用（中国专家共识） 脂必泰胶囊临床应用中国专家共识 ·合理用药 合理使用阿片类处方药 关注甲氨蝶呤片的误用风险 分娩镇痛药的合理使用 ·药物警戒 CDFA 修订全身用氟喹诺酮类药品说明书 FDA 提示：警惕葡萄柚汁和一些药物相互作用 牛奶过敏患者禁用含乳糖的甲泼尼龙注射剂 加拿大卫生部提示含碘造影剂可导致部分患者甲状腺功能减退 欧盟限制线型含钆对比剂使用 抗菌药物 嗜麦芽窄食单胞菌的抗菌药物选择 氟康唑可用于光滑念珠菌血症患者的初始治疗 ·科研动态 科学家发明“分子诱饵”，不用抗生素也能除掉细菌 “神药”二甲双胍，又有新发现 ·专项点评 脾多肽注射液临床使用专项点评分析报告