Articles by Thomas A. Little, PhD - BioPharm International

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Articles by Thomas A. Little, PhD

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

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

Design space generation is encouraged in new product development.
Sep 1, 2014

Design space generation is encouraged in new product development.

Accelerated Stability Modeling

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

Design of experiment is a powerful development tool for method characterization and method validation.
Mar 1, 2014

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

Essentials in Establishing and Using Design Space

Knowledge of product or process acceptance criterion is crucial in design space.
Sep 1, 2013

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

Essentials in Stability Analysis and Expiry Determination

The author discusses the need for stability analysis.
Jul 1, 2013

The author discusses the need for stability analysis.

Essentials in Quality Risk Management

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

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

Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.
Jul 1, 2012

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

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