BioPharm International-10-01-2003

BioPharm International

Analytical Advances: New Techniques for Detecting Leaks

October 01, 2003

Columns and Departments

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Helium Out-Detects Soap and Water

Validation of Commercial-Off-the-Shelf Calibration Management Systems: Managing Instruments Cost-Effectively

October 01, 2003

Product Development Issues

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Biotech companies are among the most intensive instrumentation users of any FDA-regulated business. Because of the complex nature of these companies' research and manufacturing, they typically have a larger number of instruments per employee.

Inside Washington: FDA Revises Policies for Biologics and Drugs

October 01, 2003

Columns and Departments

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New proposals encourage computerized systems and aim to simplify post-approval changes and avoid problems with sterile products.

Achieving Commercial Readiness: A Five-Step Program Speeds Commercialization

October 01, 2003

Product Development Issues

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Congratulations - your emerging biotechnology company is within sight of its first Biological License Application (BLA). This is the culmination of years of research and clinical development.

Outsourcing Outlook: Outsourcing Is Front Page News in 2003

October 01, 2003

Columns and Departments

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Outsourcing is in the public eye as politicians debate the lag in job growth despite a recovering economy, and the Bush Administration seeks to ?competitively source? more agency activities.

Statistical Testing for Outliers: Calculating the Critical Point of the Extreme Studentized Deviation Using the Beta Inverse Function

October 01, 2003

Product Development Issues

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When analyzing data, you will sometimes find one value that is far from the others. Such a value is called an outlier. When you encounter an outlier, you may be tempted to delete it from the analysis. Assuming that the data point is not attributable to obvious experimental mistakes, do you keep it or delete it?