A quality by design study applied to an industrial pharmaceutical fluid bed granulation-Reference-Cited by-同舟云学术

A quality by design study applied to an industrial pharmaceutical fluid bed granulation

Published:2012-06 Issue:2 Volume:81 Page:438-447
ISSN:0939-6411
Container-title:European Journal of Pharmaceutics and Biopharmaceutics
language:en
Short-container-title:European Journal of Pharmaceutics and Biopharmaceutics

Author:

Lourenço Vera,Lochmann Dirk,Reich Gabriele,Menezes José C.,Herdling Thorsten,Schewitz Jens

Publisher

Elsevier BV

Subject

Pharmaceutical Science,General Medicine,Biotechnology

Reference20 articles.

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2. FDA, Guidance for Industry: PAT, A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, Technical Report, 2004.

3. FDA, Guidance for Industry: Process Validation – General Principles and Practices, Technical Report, 2011.

4. ICH, Guideline Q9: Quality Risk Management, Technical Report, 2005.

5. ICH, Guideline Q10: Pharmaceutical Quality System, Technical Report, 2008.

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