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

ADVERTISEMENT

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).


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

AbbVie/Shire Deal Officially Off
October 20, 2014
Amgen Sues Sanofi and Regeneron over Patent for mAb Targeting PCSK9
October 20, 2014
EMA Works to Speed Up Ebola Treatment
October 20, 2014
Lilly to Close Manufacturing Facility in Puerto Rico
October 17, 2014
BioReliance Introduces New Predictive Assays
October 17, 2014
Author Guidelines
Source: BioPharm International,
Click here