Statistical Methods Articles - BioPharm International

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Statistical Methods Articles

Demonstrating Comparability of Stability Profiles Using Statistical Equivalence Testing

March 1, 2011

The authors present an approach for testing statistical equivalence of two stability profiles.

Statistical Equivalence Testing for Assessing Bench-Scale Cleanability

February 1, 2010

The two-one-sided t-test compares the equivalency of two data sets.

Use of Change-Point Analysis for Process Monitoring and Control

August 1, 2009

A better method for trend analysis than CUSUM and control charts.

Statistical Essentials—Part 4: Regression and Design of Experiments

November 1, 2008

Well-designed experiments can reduce the risk of coming to an incorrect conclusion during a process characterization, assay validation, or process validation study.

Minimizing the Problem of OOS

September 1, 2008

Statistical methods for calculating confidence intervals, tolerance intervals, and capability analysis to reduce out-of-specification situations.

Coming to a Biotech Near You: Quality by Design Part 2: Design Space in Development and Manufacturing

July 1, 2008

Quality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings.

The Power of Hypothesis

June 1, 2008

How to use hypothesis correctly, and understanding the difference between one-sample, two-sample, and z-test.

Avoiding the Pain of Out-of-Specification Results

June 1, 2008

Improving your quality operations by using sound statistical principles.

Cumulative Sum Charts for Problem Solving

May 1, 2008

CUSUM charts are easy to create in Excel and can reveal when a change occurred.

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