Analytical Best Practices - BioPharm International


Analytical Best Practices

Developing Representative Sampling Plans for Development, Problem Solving, and Validation

November 1, 2014

The ability to define a scientifically justified and statistically sound sampling procedure is a fundamental skill in modern systematic drug development.

Evaluating Design Margin, Edge of Failure, and Process Capability

September 1, 2014

Design space generation is encouraged in new product development.

Accelerated Stability Modeling

May 1, 2014

Characterization of stability performance provides a clear, statistically defendable method for determining accelerated stability.

Design of Experiments for Analytical Method Development and Validation

March 1, 2014

Design of experiment is a powerful development tool for method characterization and method validation.

Understanding and Modeling Product and Process Variation

December 1, 2013

Variation understanding and modeling is a core component of modern drug development.

Performing a Protein Purity Analysis Comparability Study

October 1, 2013

A well-designed comparability study can demonstrate the performance and advantages that can be gained when adopting a new protocol.

Essentials in Establishing and Using Design Space

September 1, 2013

Knowledge of product or process acceptance criterion is crucial in design space.

Essentials in Stability Analysis and Expiry Determination

July 1, 2013

The author discusses the need for stability analysis.

Essentials in Quality Risk Management

May 1, 2013

Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.



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