收藏切换
Discussion on the classification,acceptance criteria and assessment approaches of the change of analytical procedure
收藏切换
PDF
Rong-die ZHU1, Ying GENG2, Ying DU2, De-jiang TAN2, *, Hua CHEN2, Zhi-jun QIU1
Chinese Journal of Pharmaceutical Analysis | 2024, 44(4) : 562 - 566
Less
收藏切换
Chinese Journal of Pharmaceutical Analysis | 2024, 44(4): 562-566
Review & Monography
Discussion on the classification,acceptance criteria and assessment approaches of the change of analytical procedure
Full
Rong-die ZHU1, Ying GENG2, Ying DU2, De-jiang TAN2, *, Hua CHEN2, Zhi-jun QIU1
Affiliations
  • 1.Beijing Union Pharmaceutical Factory LTD, Beijing 102629, China
  • 2.National Institutes for Food and Drug Control, Beijing 102629, China
Published: 2024-04-30 doi: 10.16155/j.0254-1793.2024.04.02
Outline
收藏切换

The change of analytical procedure, a part of the entire lifecycle of a method, is increasingly valued with the emergence of new technologies, the increasing demand for product quality, 3R, environmental protection, and cost reduction requirements. This paper refers to the latest progress in the study of counterpart law at home and abroad, systematically classifies changes of analytical procedures from the perspective of methodology, and discusses the differences between different types of changes and the evaluation criteria and implementation approaches of analytical procedures after procedure changes.

change of analytical procedure  /  alternative of analytical procedure  /  transfer of analytical procedure  /  improvement of analytical procedure  /  equivalence test  /  non-inferior test  /  prediction interval  /  tolerance interval
Rong-die ZHU, Ying GENG, Ying DU, De-jiang TAN, Hua CHEN, Zhi-jun QIU. Discussion on the classification,acceptance criteria and assessment approaches of the change of analytical procedure[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (4) : 562 -566 . DOI: 10.16155/j.0254-1793.2024.04.02
Year 2024 volume 44 Issue 4
PDF
106
47
Cite this Article
BibTeX
Article Info
doi: 10.16155/j.0254-1793.2024.04.02
  • Receive Date:2023-11-14
  • Online Date:2026-03-13
  • Published:2024-04-30
Article Data
Affiliations
History
  • Received:2023-11-14
Affiliations
    1.Beijing Union Pharmaceutical Factory LTD, Beijing 102629, China
    2.National Institutes for Food and Drug Control, Beijing 102629, China
References
Share
https://castjournals.cast.org.cn/joweb/ywfxzz/EN/10.16155/j.0254-1793.2024.04.02
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT