Risk-based approach for method development in pharmaceutical quality control context: A critical review-Reference-Cited by-同舟云学术

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Risk-based approach for method development in pharmaceutical quality control context: A critical review

Published:2018-11 Issue: Volume:161 Page:110-121
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Deidda Riccardo,Orlandini Serena^ORCID,Hubert Philippe,Hubert Cédric^ORCID

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference81 articles.

1. Quality risk management Q9;ICH Harmonised Tripartite Guideline,2005

2. Pharmaceutical CGMPs for the 21st century – A Risk-Based Approach. Final report (2004) U.S Food and Drug Administration.

3. A quality control method enhancement concept – continual improvement of regulatory approved QC methods;Åsberg;J. Pharm. Biomed. Anal.,2016

4. Life cycle management of analytical methods;Parr;J. Pharm. Biomed. Anal.,2018

5. Design Spaces for analytical methods;Rozet;Trends Analyt. Chem.,2013

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