Pharmaceutical Outsource Solutions is making available a forum where individuals may present position papers supporting practices that they consider to be industry "Best Practices". These views may propound activities that are not commonly performed, mandated by a regulatory agency, or even industry standard, but are considered by the author to be an activity important for consideration by the pharmaceutical and biotechnology community.
Note: The full articles listed below require Adobe Acrobat Reader to be viewed.
January 2010: "Update Bioanalytical Methods Prior to Submitting Studies to the FDA", Scharberg, D.
Description: A warning that the FDA expects all bioanalytical methods to be current at the time of submission, even if the requirements have changed since the work was originally performed. [View the abstract / full article]
January 2008: "Four Lessons from MDS Montreal", Scharberg, D.
Description: Lessons that all sponsors should learn about taking responsibility for the bioanalytical data generated in support of their clinical programs. [View the abstract / full article]
April 2007: "Critical Recommendations from the Third AAPS/FDA Bioanalytical Workshop", Scharberg, D
Advice is given on the implementation of several critical recommendations from the Third AAPS/FDA Bioanalytical Workshop. [View the abstract / full article]
April 2006: "Ten Questions to Ask Your Prospective Contract Laboratory", Scharberg, D.
Description: Initiating work at a new contract laboratory can be difficult. Here are ten questions that should be asked to determine if a prospective laboratory really is the best organization to support your activities. [View the abstract / full article]
June 2004: "Quality Control Samples", Scharberg, D.
Description: Quality Control samples are vital for the validation and batch-level quality control of bioanalytical methods. However, they must be made and used in an appropriate function to perform their function. [View the abstract / full article]
February 2004: "How Product Failures are Related to Raw Materials", Scharberg, D.
Description: Many product failures are related directly to the false assumptions and poor practices used in acquiring and approving raw materials. [View the abstract / full article]
October 2003: "A Rational Approach to Qualifying a Contract GMP Testing Laboratory", Scharberg, D.
Description: Sponsors should submit "test samples" to contract GMP testing laboratories to be used as the basis for performing compliance and technical assessments as part of a qualification process. [View the abstract / full article]
May 2003: "The Use of Internal Standard Calibration with LC/MS/MS Bioanalytical Methods", Holstege, Ph.D., D.
Description: Internal standards used for LC/MS/MS bioanalytical methods should be isotopically labeled forms of the analyte to ensure method performance and minimize sample reanalysis. [View the abstract / full article]