How to Maintain Suitable Analytical Test Methods: Tools for Ensuring a Validation Continuum - - BioPharm International

ADVERTISEMENT

How to Maintain Suitable Analytical Test Methods: Tools for Ensuring a Validation Continuum


BioPharm International


REFERENCES:

1. International Conference on Harmonisation; Guideline on Validation of Analytical Procedures (Q2A). 60 Federal Register 11259-11262 (1995).

2. International Conference on Harmonisation; Guideline on Validation of Analytical Procedures: Methodology (Q2B). Federal Register 27463-27467 (1997).

3. Krause SO. Qualifying Release Laboratories in Europe and the United States. BioPharm International. 2004; 17 (3):28-36.

4. Krause SO. Development and validation of analytical methods for biopharmaceuticals, part I: development and optimization. BioPharm International. 2004; 17(10):52-61.

5. Krause SO. Development and validation of analytical methods for biopharmaceuticals, part II: formal validation. BioPharm International. 2004; 17(11):46-52.

6. Krause SO. Analytical Method Validation for Biopharmaceuticals, BioPharm International Guide to Validation. 2005; 24-32.

7. Krause SO. Submitting Advanced Bioanalytical Test Methods for Regulatory Approval. BioPharm International Guide to Bioanalytical Advances. 2005; 21-27.

8. United States Pharmacopoeia (USP). General Chapter in Draft, <1226> Verification of Compendial Procedures, Pharmacopeial Forum, 2005.

9. Fuege J. The Validation Continuum: An FDA Perspective, Presented by Mary Malarkey, Journal of Validation Technology. 2005; 11(3):253-6.

10. Krause SO. Analytical Method Validation for Biopharmaceuticals. Invited General Session Presentation, IBC International Conference: Quality Systems and Regulatory Compliance, Reston, VA, April 05, 2005.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Bristol-Myers Squibb and Five Prime Therapeutics Collaborate on Development of Immunomodulator
November 26, 2014
Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
November 25, 2014
FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
November 25, 2014
AstraZeneca Expands Biologics Manufacturing in Maryland
November 25, 2014
GSK Leads Big Pharma in Making Its Medicines Accessible
November 24, 2014
Author Guidelines
Source: BioPharm International,
Click here