Implementation of Quality by Design Approach for Developing Chromatographic Methods with Enhanced Performance: A Mini Review

Author:

Suman Panda Sagar

Publisher

MedCrave Group, LLC

Subject

General Medicine

Reference24 articles.

1. ICH (2009) Technical Requirements for the Registration of Pharmaceuticals for Human Use, Pharmaceutical development Q8 (R2). Harmonised Tripartite Guideline, p: 1-28.

2. US FDA (2003) FDA's Pharmaceutical current Good Manufacturing Practices (cGMPs) for the 21st Century-A risk-based approach: Final report.

3. Expanding the term "Design Space" in high performance liquid chromatography (I);Monks;J Pharm Biomed Anal 56(5),2011

4. Quality by Design:Concepts for ANDAs;Lionberger;AAPS J 10(2),2008

5. Quality by design (QbD) based method development and validation of an HPLC method foe amiodarone hydrochloride and its impurities in the drug substance;Karmarkar;J Pharm Biomed Anal,2014

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