|
Limit for Nitroso Lisinopril
|
|
0
|
416
|
July 7, 2022
|
|
Nitroso Sotalol Limit?
|
|
0
|
334
|
July 7, 2022
|
|
Nitrosamine in fermentation based product
|
|
0
|
524
|
July 7, 2022
|
|
Nitrosamines in veterinary medicinal products
|
|
1
|
604
|
July 6, 2022
|
|
Nitrosamines from excipients : Query
|
|
4
|
603
|
June 30, 2022
|
|
Api或起始物料中亚硝酸盐限度
|
|
1
|
569
|
June 29, 2022
|
|
NDEA AI Limit 26.5ng/day?
|
|
17
|
2076
|
June 23, 2022
|
|
Limits more than one Nitrosamine?
|
|
35
|
2344
|
June 23, 2022
|
|
Using SAR to evaluate hazard and potency (Recording)
|
|
0
|
410
|
June 20, 2022
|
|
Setting Nitrosamine Impurity limits
|
|
5
|
744
|
February 27, 2022
|
|
7,080 in vitro genetox study records for 500 nitrosamines?
|
|
3
|
314
|
February 24, 2022
|
|
Limits for NDIPA
|
|
1
|
310
|
February 4, 2022
|
|
Nitrosamine impurities in drug product specification
|
|
11
|
760
|
February 2, 2022
|
|
Calculation of limit when more than one nitrosamine is identified
|
|
8
|
1005
|
January 9, 2022
|
|
Any experience on this structure?
|
|
7
|
547
|
December 20, 2021
|
|
AIs for Complex Nitrosamines by MW Adjustments, any experience?
|
|
4
|
617
|
December 16, 2021
|
|
Laboratory analysis of varenicline products by FDA
|
|
14
|
1123
|
November 23, 2021
|
|
Advices are needed for LTL approach
|
|
4
|
471
|
October 15, 2021
|
|
Why LTL approach is not been considered?
|
|
18
|
2317
|
August 25, 2021
|
|
Nitrosamine SAR resources by Dr. Kevin Cross
|
|
1
|
671
|
August 13, 2021
|
|
Limits calculation a true mystery, help to understand NMPA?
|
|
3
|
612
|
August 10, 2021
|
|
FDA / clinical trial Exposure to NDMA after taking ranitidine
|
|
5
|
823
|
August 6, 2021
|
|
What are FDA’s expectations for establishing acceptable intakes (Als) for potential cohort of concern (CoC) nitrosamines with insufficient safety data?
|
|
0
|
305
|
July 20, 2021
|
|
Regulatory Experience
|
|
1
|
218
|
July 2, 2021
|
|
Robust assessment of exposure limits compared with simple linear extrapolations
|
|
0
|
179
|
June 14, 2021
|
|
If in-vivo assay is negative for Nitrosamine impurity, can it limit increase as per ICH Q3AB?
|
|
0
|
227
|
June 1, 2021
|
|
Shall we refer to M7 to calculate AI limit of Nitrosamine for the finished product?
|
|
0
|
238
|
May 26, 2021
|
|
Good Read ... on N-nitrosamine Limits
|
|
2
|
585
|
May 21, 2021
|
|
Assessing risk from less-than-lifetime exposure, what's the right approach?
|
|
0
|
225
|
April 26, 2021
|
|
What's the right approach to address the intrinsic issue of limits?
|
|
0
|
184
|
April 19, 2021
|