Validation of a Reversed-Phase HPLC Method for Well-Characterized Biopharmaceuticals

Library Number:
980275
Author(s):
J. Carmody, B. Alden, T. Walter, J. Cook, D. Costello, R. Crowley, R. Fisk, K. Glose, and U. Neue
Source:
Poster #1614, 2nd Symposium on the Analysis of Well-Characterized Biotechnology Pharmaceuticals, San Francisco, January 4-7, 1998
Content Type:
Posters
Content Subtype:
Other Symposium
Compounds:
Tryptic digest of bovine heart Cytochrome c
Column:
Symmetry300 C18
Dimensions:
3.9 x 150 mm
Development of analytical methods to quantitate/qualitate biopharmaceutical drug substances and their metabolites in complex matrices is not a trivial undertaking. The method itself plays an important role in the determination of the bioequivalence, bioavailability and pharmacokinetic attributes of a drug substance. It is, therefore, essential to employ a well-defined, fully validated analytical method that has the ability to yield reliable results.

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