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Evaluating change during pharmaceutical product development and manufacture-comparability and equivalence

  • Published:2011-07 Issue:5 Volume:27 Page:629-640
  • ISSN:0748-8017
  • Container-title:Quality and Reliability Engineering International
  • language:en
  • Short-container-title:Qual. Reliab. Engng. Int.

Author:

Chatfield Marion J.,Borman Phil J.,Damjanov Ivana

Publisher

Wiley

Subject

Management Science and Operations Research,Safety, Risk, Reliability and Quality

Reference25 articles.

1. The application of quality by design to analytical methods;Borman;Pharmaceutical Technology,2007

2. ICH 2009

3. Implications and opportunities of applying QbD principles to analytical measurements;Pohl;Pharmaceutical Technology Europe,2010

4. The development phase of an LC method using QbD principles;Borman;Separation Science,2010

5. Acceptance criteria for method equivalency assessments;Chatfield;Analytical Chemistry,2009

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