JVT Journal Articles
Vol. 17, Issue 3, Aug 2011

Quantitative determinations of polyunsaturated fatty acids (PUFAs) in human serum have been a great challenge. The quantification of individual omega 3 (ω-3) and omega 6 (ω-6) fractions has not been accomplished to date. Instruments used for the analyses of PUFAS include gas chromatography (GC), thin layer chromatography (TLC), and high-performance liquid chromatography (HPLC) that obtain the total amount of PUFAs instead of...
Bernard McGarvey
,
Brian K. Nunnally
,
John McConnell
KEY POINTS DISCUSSED The following key points are discussed:
William R. Porter, Ph.D.
Factors impacting the achievement of drug product stability by design are reviewed. A strategy for the development team is proposed using the standard quality by design pathway developed by Juran. Stability goals are established after consultation with suppliers, teammates, and stakeholders. Virtual failure mode analysis is used to identify the “...
The following key points are discussed: Analysis of covariance (ANCOVA) is an important kind of multiple regression that involves two predictor variables: one continuous (e.g., time) and one categorical (e.g., batch of material). Like simple linear regression, simple ANCOVA fits straight lines to response measurements (e.g., potency, related...
Gregory P. Martin
,
Vivian A. Gray
The following key points are discussed: Selection of the dissolution medium to be used for quality control dissolution testing is the most critical part of dissolution method development. The analytical target profile (ATP) and drug substance solubility are key factors in dissolution medium selection. The ATP should indicate the type of...
Scott Sutton, Ph.D.
The following key points are discussed: Microbiological data are inherently variable. The “plate count” is at best an interpretation of an approximation of the number of cells present. The linear range for common bacterial counts on standard sized plates is established. Unusual plate count situations occur and should be covered by a standard...
Paul L. Pluta, Ph.D.
The following key points are discussed: Validation managers identified documentation problems as one of their most troubling problems. Documentation problems are prevalent at all stages of process qualification (i.e., plans, protocols, and results). Problems generally included the following: Incomplete and inadequate content Explanations...
Conventional approaches for setting cleaning validation acceptance limits for multiproduct (i.e., shared) equipment are often more stringent than necessary. Furthermore, the acceptance limits derived using these approaches can be impractical to achieve or below the limit of quantitation (LOQ) of the analytical method. Practical solutions to these...
John E. Lincoln
The following key points are discussed: Methodology and documentation required by the US Food and Drug Administration to effectively verify, test, and validate software or firmware that is in a medical device Software validation is required for software used in-product, as-product, in processes, facilities, or in quality systems FDA has...

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