Articles by Thomas A. Little, PhD - BioPharm International



Articles by Thomas A. Little, PhD

Thomas A. Little, PhD

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.

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.

Assay Development and Method Validation Essentials
November 1, 2012

A 10-step systematic approach to analytical method development and validation can improve the quality of drug development.

Using a Systematic Approach to Select Critical Process Parameters
July 1, 2012

Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.



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