| 查看: 1941 | 回复: 17 | |||
| 【奖励】 本帖被评价14次，作者1949stone增加金币 10.2 个 | |||
[资源]
Leachables and Extractables Workshop Documents
|
|||
|
Posters Introduction To Polymer Additives And Stabilization The Analytical Evaluation Threshold Analysis of Mercaptobenzothiazole (MBT) Compounds from Sulfur Cured Rubber by a Liquid Chromatography Case Study: Method Optimization and Extractables Characterization of a Peroxide Cured Rubber Controlled Extraction Study “Unknown” Elastomer Controlled Extraction Study On Polypropylene Test Article Summary of the PQRI Leachables and Extractables Recommendations Safety Qualification Thresholds for Leachables in OINDP Validation Of Extractables And Leachables Method For A Sulfur-Cured Elastomer Presentations Day 1 Workshop on Leachables and Extractables (Terry Tougas) Challenges in Orally Inhaled and Nasal Drug Products (Gordon Hansen) Leachables and Extractables in OINDP: An FDA Perspective (Alan Schroeder) Threshold Of Toxicological Threshold Of Toxicological Concern (TTC) In Risk Assessment (Robert Kroes) Derivation and Justification of Safety Thresholds (Doug Ball) Best Practices for Leachables and Extractables Testing (Daniel Norwood) Specifics of Safety Recommendations (David Jacobson Kram) Development and Justification of a Safety Concern Threshold (Mark Vogel) Development and Justification of Qualification Threshold (Ron Wolf) Safety Qualification Process and Application of Thresholds (James Blanchard) Wrap Up of Day 1, Looking Forward to Day 2 (Lee Nagao) Day 2 Opening Remarks – Day 2 (Diane Paskiet) Container Closure System Components Composition and Selection (Fran DeGrazio) Controlled Extraction Studies (Tom Feinberg) Leachable Studies and Routine Extractables Testing (Diane Paskiet) Development and Application of the Analytical Evaluation Threshold (Daniel Norwood) Summary of Discussions (Lee Nagao) Safety Recommendations: Science and Process (Tim McGovern) Best Practices Recommendation: Regulatory Science Strategies (Guirag Poochikian) Direction for Leachables/Extractables (Helen Winkle) |
回复此楼» 本帖附件资源列表
-
欢迎监督和反馈：小木虫仅提供交流平台，不对该内容负责。
本内容由用户自主发布，如果其内容涉及到知识产权问题，其责任在于用户本人，如对版权有异议，请联系邮箱：xiaomuchong@tal.com - 附件 1 : AlanSchroederDay1.pdf
- 附件 2 : DanNorwoodDay1.pdf
- 附件 3 : DanNorwoodDay2.pdf
- 附件 4 : DavidJacobsonKramDay1.pdf
- 附件 5 : DeGrazioDay2.pdf
- 附件 6 : DianePaskietChemSessionDay2.pdf
- 附件 7 : DianePaskietDay2.pdf
- 附件 8 : GordonHansenDay1.pdf
- 附件 9 : GuiragPoochikianDay2.pdf
- 附件 10 : HelenWinkleDay2.pdf
- 附件 11 : JimBlanchardDay1.pdf
- 附件 12 : LeeNagaoDay2.pdf
- 附件 13 : LeeNagaoWrapUpDay1.pdf
- 附件 14 : Polymer_Additives_PQRI_Poster.pdf
- 附件 15 : PQRI_AET_Poster.pdf
- 附件 16 : PQRI_MBT_Poster.pdf
- 附件 17 : PQRI_Peroxide_Elastomer_Extraction_Poster.pdf
- 附件 18 : PQRI_peroxide_workshop_poster.pdf
- 附件 19 : PQRI_Polypropylene_Extraction_Poster.pdf
- 附件 20 : PQRI_Recommendations_Poster.pdf
- 附件 21 : PQRI_Safety_Poster.pdf
- 附件 22 : RobertKroesDay1.pdf
- 附件 23 : Sulfur_Cured_Elastomer_PQRI_Poster.pdf
- 附件 24 : TerryTougasDay1.pdf
- 附件 25 : ThomasFeinbergDay2.pdf
- 附件 26 : TimMcGovernDay2.pdf
- 附件 27 : WolffDay1.ppt
2015-09-22 21:00:19, 236.49 K
2015-09-22 21:00:25, 761.54 K
2015-09-22 21:00:27, 150 K
2015-09-22 21:00:38, 986.44 K
2015-09-22 21:00:39, 79.78 K
2015-09-22 21:00:41, 238.18 K
2015-09-22 21:00:42, 49.72 K
2015-09-22 21:00:44, 162.84 K
2015-09-22 21:00:45, 81.9 K
2015-09-22 21:00:47, 159.7 K
2015-09-22 21:00:49, 173.12 K
2015-09-22 21:00:49, 21.51 K
2015-09-22 21:00:50, 16.11 K
2015-09-22 21:00:56, 732.96 K
2015-09-22 21:00:57, 116.54 K
2015-09-22 21:00:59, 97.79 K
2015-09-22 21:01:01, 181.59 K
2015-09-22 21:01:03, 142.52 K
2015-09-22 21:01:04, 68.98 K
2015-09-22 21:01:08, 457.75 K
2015-09-22 21:01:11, 139.74 K
2015-09-22 21:01:17, 568.02 K
2015-09-22 21:01:22, 535.22 K
2015-09-22 21:01:23, 34.79 K
2015-09-22 21:01:25, 205.24 K
2015-09-22 21:01:27, 191.54 K
2015-09-22 21:01:32, 472.5 K
» 收录本帖的淘帖专辑推荐
 仿制药研发申报 |
» 本帖已获得的红花（最新10朵）
lwrence» 猜你喜欢
家人们做LDH为啥会出现负值啊
已经有0人回复
-
有偿求肠毒素的脆弱拟杆菌（ETBF）
已经有0人回复
-
药物学论文润色/翻译怎么收费?
已经有245人回复
-
广西医科大学基础医学院自身免疫病课题组招收基础医学、药学和生物学等专业的研究生
已经有7人回复
-
[学习资料分享] FAERS数据库的不良反应挖掘(频数法/贝叶斯法)
已经有1人回复
-
招收医学、基础医学类调剂研究生
已经有0人回复
-
是否属于脾肾阳虚证
已经有0人回复
» 本主题相关价值贴推荐，对您同样有帮助:
- Extractables & Leachables for Pharmaceutical Products 2011
已经有36人回复
- Pharmaceutical Industry Practices on Genotoxic Impurities (2015出版)
已经有190人回复
- ！！！！！！！！！！！！！！4372页药物技术百科全书 4th 高清
已经有169人回复
- 求助英文书籍一本，非常感谢
已经有4人回复
- 求助书籍一本
已经有2人回复
- The management of extractables and leachables in pharmaceutical products
已经有3人回复
- 求wiley图书一本
已经有3人回复
3楼2015-09-23 07:18:03
8楼2015-09-23 16:47:00
9楼2015-09-24 14:46:22
10楼2015-09-24 15:15:41
11楼2015-09-24 19:13:19
13楼2015-11-15 11:59:17
18楼2018-08-15 16:17:31
简单回复
pingshan2楼
2015-09-22 21:55
回复
五星好评 顶一下，感谢分享！
lyb51504楼
2015-09-23 07:28
回复
三星好评 
2015-09-23 08:17
回复
五星好评 顶一下，感谢分享！
yanzr6楼
2015-09-23 12:39
回复
五星好评 顶一下，感谢分享！
zf8306197楼
2015-09-23 15:20
回复
五星好评 顶一下，感谢分享！
xuxiao6412楼
2015-09-25 17:49
回复
五星好评 顶一下，感谢分享！
quietdon14楼
2015-12-09 13:39
回复
五星好评 顶一下，感谢分享！
lydia307915楼
2017-06-23 14:07
回复
五星好评 顶一下，感谢分享！
wslld16楼
2018-05-30 11:46
回复
五星好评 顶一下，感谢分享！
lwrence17楼
2018-08-15 16:17
回复
五星好评 赞