A Guide for Testing Biopharmaceuticals Part 2: Acceptance criteria and analytical method maintenance - - BioPharm International

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A Guide for Testing Biopharmaceuticals Part 2: Acceptance criteria and analytical method maintenance


BioPharm International
Volume 19, Issue 10

REFERENCES

1. S.O. Krause, Pharm. Technol. Eur. 18(5) 2006.

2. S.O. Krause, BioPharm International. 8(10):52–59 (2005).

3. Guidance for Industry (CDER/CVM/ORA, US FDA). PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004.

4. ICH. Pharmaceutical Development, Q8, November 2005.

5. ICH. Quality Risk Management, Q9, November 2005.

6. ICH. Quality Systems. Q10. In draft.

7. S.O. Krause, Analytical Method Validation for Biopharmaceuticals, General Session Presentation, IBC International Conference: Quality Systems and Regulatory Compliance (Reston, VA, April 05, 2005).

8. F. Brown and A. Mire-Sluis (eds): The Design and Analysis of Potency Assays for Biotechnology Products. Dev Biol, Karger, 107(1), 117–127 (2002).


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