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

Lilly to Acquire Novartis Animal Health
April 22, 2014
Novartis and GSK Trade Assets
April 22, 2014
Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
EMA Warns of Falsified Herceptin Vials
April 16, 2014
American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
Author Guidelines
Source: BioPharm International,
Click here