REVERSED-PHASE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT IN AN ANALYTICAL QUALITY BY DESIGN FRAMEWORK-Reference-Cited by-同舟云学术

REVERSED-PHASE LIQUID CHROMATOGRAPHIC METHOD DEVELOPMENT IN AN ANALYTICAL QUALITY BY DESIGN FRAMEWORK

Published:2013-08 Issue:18 Volume:36 Page:2612-2638
ISSN:1082-6076
Container-title:Journal of Liquid Chromatography & Related Technologies
language:en
Short-container-title:Journal of Liquid Chromatography & Related Technologies

Author:

Reid George L.¹,Cheng Guilong¹,Fortin David T.¹,Harwood Jeffrey W.¹,Morgado James E.¹,Wang Jian¹,Xue Gang¹

Affiliation:

1. a Analytical Research and Development, Pfizer Worldwide Research and Development , Groton , Connecticut , USA

Publisher

Informa UK Limited

Subject

Clinical Biochemistry,Pharmaceutical Science,Biochemistry,Analytical Chemistry

Link

https://www.tandfonline.com/doi/pdf/10.1080/10826076.2013.765457

Reference31 articles.

1. International Conference on Harmonization (ICH). Q8(R2): Pharmaceutical Development (August 2009). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf

2. International Conference on Harmonization (ICH). Q9: Quality Risk Management (November 2005). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf

3. International Conference on Harmonization (ICH) Q11: Development and Manufacture of Drug Substances Draft Guideline (May 2011). http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf

Cited by 35 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. Stability-Indicating UPLC-PDA-QDa Methodology for Carvedilol and Felodipine in Fixed-Dose Combinations Using AQbD Principles;Scientia Pharmaceutica;2024-04-25

2. Estimation of Lexisinatide in Bulk and Tablets by RP‐UPLC Method Developed by Quality by Design Concept;Macromolecular Symposia;2024-04

3. Discriminative Dissolution Method Development Through an aQbD Approach;AAPS PharmSciTech;2023-12-08

4. Definições e escopo dos elementos-chave do Analytical Quality by Design (AQbD) para o desenvolvimento de métodos na indústria farmacêutica;Vigilância Sanitária em Debate;2023-10-05

5. Drilling into “Quality by Design” Approach for Analytical Methods;Critical Reviews in Analytical Chemistry;2023-09-04