Submitting Advanced Bioanalytical Test Methods for Regulatory Approval - - BioPharm International

ADVERTISEMENT

Submitting Advanced Bioanalytical Test Methods for Regulatory Approval


BioPharm International


References:

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

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

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

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

5. ICH. Validation of Analytical Procedures. Q2A. Federal Register 1995; 60.

6. ICH. Validation of Analytical Procedures: methodology. Q2B. Federal Register 1996; 62.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

Merck KGaA Announces Acquisition of Sigma-Aldrich for $17 Billion
September 22, 2014
Pandemic Vaccine Facility Dedicated in Texas
September 19, 2014
Guideline Delineates How to Implement GS1 Standards to Support DSCSA
September 19, 2014
GSK Fined in China Bribery Scandal
September 19, 2014
GPhA Supports Restricted Access Bill
September 18, 2014
Author Guidelines
Source: BioPharm International,
Click here