Quality by Design Compliant Analytical Method Validation-Reference-Cited by-同舟云学术

Quality by Design Compliant Analytical Method Validation

Published:2011-12-08 Issue:1 Volume:84 Page:106-112
ISSN:0003-2700
Container-title:Analytical Chemistry
language:en
Short-container-title:Anal. Chem.

Author:

Rozet E.¹,Ziemons E.¹,Marini R.D.¹,Boulanger B.²,Hubert Ph.¹

Affiliation:

1. Analytical Chemistry Laboratory, CIRM, Institute of Pharmacy, University of Liège, Liège, Belgium

2. Arlenda SA, Liège, Belgium

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/ac202664s

Reference33 articles.

1. Topic Q8 (R2): Pharmaceutical Development.International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland, 2009.

2. U.S. Food and Drug Administration (FDA), Department of Health and Human Services. Pharmaceutical Quality for the 21st Century:A Risk-Based Approach Progress Report, May (2007.http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm128080.htm.

3. Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control

4. Development of Quality-By-Design Analytical Methods

5. A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603)

Cited by 50 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. QbD Assisted Development and Validation of UV Spectroscopic Method in Estimation of Silymarin;Letters in Drug Design & Discovery;2024-04

2. Development and Validation of a UV Spectroscopic Method to Estimate Eltrombopag Olamine along with Bulk and In-house Formulation;Research Journal of Pharmacy and Technology;2023-11-30

3. An Overall Validation Approach Based on β-Content, γ-Confidence Tolerance Interval, and Uncertainty Profile: Application to LC–MS/MS Quantification of Carbendazim in Drinking Water;Journal of AOAC International;2023-03-06

4. Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies;Pharmacia;2023-01-09

5. Validation of liquid chromatographic methods;Liquid Chromatography;2023