Michael Swartz and Ira Krull are the co-editors of "Validation Viewpoint." Michael is a research director at Synomics Pharmaceutical Services, LLC, Wareham, Massachusetts, while Ira is associate professor of chemistry at Northeastern University, Boston, Massachuetts. Both are members of LCGC's editorial advisory board.
 | July 1, 2009
By:Michael Swartz, Ira Krull
The authors explore how true (complete) method validation of biopharmaceuticals must be forthcoming.
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 | November 1, 2008
By:Ira Krull, P.T. Kissinger, Michael Swartz
While the "Validation Viewpoint" column has focused on conventional and recombinant pharmaceutical products, and at times, bioanalytical methods, we have just begun to think about method validation as it relates to -omics type studies.
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 | August 1, 2008
By:Candice B. Kissinger, Peter T. Kissinger, Ira Krull, Michael Swartz
A very useful construct in engineering and analytical chemistry is the concept of a time-invariant linear system. The properties of the system (as for a mathematical function) are defined by a relationship between the response and the excitation, and ...
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 | May 1, 2008
By:Michael Swartz, Ira Krull
To obtain a better understanding of the challenges faced during method development and validation, the authors — in cooperation with LCGC — conducted a survey earlier this year. This column summarizes the results.
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 | February 1, 2008
By:Michael Swartz, Ira Krull
This month's "Validation Viewpoint" installment highlights some method validation guidelines used in developing and validating dissolution test procedures.
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 | December 1, 2007
By:Michael Swartz, Ira Krull
This installment of "Validation Viewpoint" column addresses, in the hopes of clarifying what the biopharmaceutical industry is required to do today to identify and quantify impurities in their biotech, proteinaceous products.
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