I. The rationale for extended-release pharmaceuticals II. Terminology III. Extended-release oral dosage forms IV. Delayed-release oral dosage forms V. USP requirements and FDA Guidance for modified-release dosage forms VI. Clinical considerations in the use of oral modified-release dosage form VII. Packaging and storing modified-release tablets and capsules

大家好，我叫 Barbara O’Neill，是质量标准的高级经理。我的工作经历包括参加临床 试验和代表制药公司进行稽查，今天讲课的内容是对临床试验单位的稽查。 在今天的课程中，我们主要讲的内容是：稽查的定义，FDA 视察， 申办者稽查以及视 察和稽查中常见的问题。ICH-GCP 对稽查的定义如下：稽查是对试验相关的活动和文件进 行系统的、独立的检查，以确定这些试验相关的活动和数据的记录、分析和准确的报告是否 与试验方案、申办者的标准操作规程、GCP 以及相关的法规要求相符

N-methylcarbamate insecticide residues, including carbamate metabolites, are ex￾tracted with methanol. The extract is cleaned up by partitioning and column chromatography on a charcoal/Celite column. Residues are selectively determined

PERCENTAGE FAT, WATER, AND SUGARS IN FOODS Methods in Chapters 3 and 4 are usually designated as applicable to either fatty

1 Codes: C: complete (>80%); P: partial (50-80%); S: small (<50%); V: variable (approximate percentage when known); R: recovered but no quantitative information available; NR: not recovered

Use of any multiresidue method (MRM) is supported by available information about how potential residues behave through the steps of the method. To provide that support for PAM I MRMs, additional chemicals are continually tested through the method steps and the resulting data compiled in a single database. All PAM

Multiresidue methodology by definition requires determinative steps capable of separating analytes from one another so each can be detected and measured individually. Both gas-liquid chromatography (GLC) and high performance liquid

In recent years, high performance liquid chromatography (HPLC) has grown in popularity as a determinative step for residue analysis, until today it is accepted as complementary to the more traditional gas liquid

美国植物药新药指南_评美国FDA的《植物药研制指导原则》

文章总结了国际上已上市干细胞药物的研究进展,比较了再生医学监管领域美国FDA、欧盟MA、日本PMDA的监管法规和技术指导原则,重点探讨了干细胞产品药学审评的一般考虑,以期为国内干细胞药物的研发与评价提供参考