Aug 1, 2008
By:
Candice B. Kissinger, Peter T. Kissinger, Ira Krull, Michael Swartz
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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 ...
May 1, 2008
By:
Michael Swartz, Ira Krull
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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.
Feb 1, 2008
By:
Michael Swartz, Ira Krull
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This month's "Validation Viewpoint" installment highlights some method validation guidelines used in developing and validating dissolution test procedures.
Dec 1, 2007
By:
Michael Swartz, Ira Krull
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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.
Aug 1, 2007
By:
Michael E. Swartz, Ira Krull
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One issue that has become clear to us throughout courses, workshops, seminars, and various talks on the subject of method validation, is that while many people talk the language, sometimes the individual method validation terms mean different things to different people. While the actual protocols, or experimental details used to measure or evaluate method validation can vary, it's a good idea to have a common understanding of the underlying terms. In this month's installment of "Validation Viewpoint," we have compiled glossary of method validation terms as they pertain to chromatography.
May 1, 2007
By:
Michael Swartz
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I was first acquainted with LCGC in the mid 1980s. Known then as just LC Magazine, it appealed to any graduate student working in the field of chromatography because it was delivered each month free of charge.
May 1, 2007
By:
Ira S. Krull
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Editor Dave Walsh suggested that current columnists for LCGC might enjoy writing about their experiences in writing their columns and relate how they got into such writings and where it has taken them.
May 1, 2007
By:
Michael Swartz, Ira Krull
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Peptide mapping is one of the preferred techniques for the comprehensive characterization of biopharmaceutical products and is often the analytical method of choice for studying a protein's primary structure.
Jan 1, 2007
By:
Victoria Lander
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The current final FDA guidance document discussing the revised scope and applicability of 21 CFR Part 11 clearly adopts a risk-based approach to Part 11 compliance. This is certainly a very pragmatic approach and one that many regulated firms had adopted even before the recent release of this document. This article will discuss the particulars of a risk-based approach to Part 11 compliance. The favored risk assessment protocols such as HACCP, FMEA and FMECA will also be addressed as well as how one can apply them to 21 CFR Part 11 compliance.
