Setting acceptance criteria for validation of analytical methods of drug eluting stents: Minimum requirements for analytical variability-Reference-Cited by-同舟云学术

Setting acceptance criteria for validation of analytical methods of drug eluting stents: Minimum requirements for analytical variability

Published:2011-02 Issue:3 Volume:42 Page:230-237
ISSN:0928-0987
Container-title:European Journal of Pharmaceutical Sciences
language:en
Short-container-title:European Journal of Pharmaceutical Sciences

Author:

Kamberi Marika,Garcia Hector,Feder Debra P.,Rapoza Richard J.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference35 articles.

1. The future of drug eluting stents;Anis;Heart,2006

2. Aberrant or atypical results: analytical process capability;Burgess,2005

3. Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production;Center for Drug Evaluation and Research (CDER),2006

4. Reviewer Guidance: Validation of Chromatographic Methods;Center for Drug Evaluation and Research (CDER),1994

5. Pharmaceutical aspects of drug eluting stents;Deconinck;Pharm. Sci.,2008

Cited by 9 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Combining Capability Indices and Control Charts in the Process and Analytical Method Control Strategy;Quality Control - Intelligent Manufacturing, Robust Design and Charts;2021-03-24

2. General principles and regulatory considerations: method validation;Specification of Drug Substances and Products;2020

3. Application of capability indices and control charts in the analytical method control strategy;Journal of Separation Science;2017-06-26

4. Stability testing of drug eluting stents;Journal of Drug Delivery Science and Technology;2016-10

5. Capability measurement of size-exclusion chromatography with a light-scattering detection method in a stability study of bevacizumab using the process capability indices;Journal of Chromatography A;2014-08