Articles & Publications

The following are publications written by Dr. Thomas A. Little and others on various aspects of statistical methods, product development, validation and process control. They have been published in a variety of journals and are available for your review. They represent industry standard practice and a practitioner's perspective on best practices for product development, data analysis and risk assessment.

Essentials in Bioassay Design and Relative Potency Determination

Published by BioPharm International

Process Characterization Essentials Part I: Process Understanding and Health Authorities Guidance

Published by BioPharm International

Establishing Acceptance Criteria for Analytical Methods

Published by BioPharm International

Essentials in Tolerance Design and Setting Specification Limits

Published by BioPharm International

Out of Trend Identification and Removal in Stability Modelling and Regression Analysis

Published by BioPharm International

Robust Optimization, Simulation and Effective Design Space

Published by BioPharm International

Method Validation Essentials, Limit of Blank, Limit of Detection and Limit of Quantitation

Published by BioPharm International

Equivalence Testing for Comparability

Published by BioPharm International

QbD Approach to Assay Development and Method Validation

Published by BioProcess International

Developing Representative Sampling Plans for Development, Problem Solving and Validation

Published by BioPharm International

Evaluating Design Margin, Edge of Failure, and Process Capability

Published by BioPharm International

Quality Risk Management for Drug Products and Drug Substances

Published by BioProcess International

Multifactor Non-linear Modeling for Accelerated Stability Analysis and Prediction

Published by Pharmaceutical Technology

Accelerated Stability Modeling

Published by BioPharm International

Design of Experiments for Method Development and Validation

Published by BioPharm International

Essentials in Quality by Design

Published by BioProcess International

Understanding and Modeling Product and Process Variation

Published by BioPharm International

Assay Development and Method Validation Essentials

Published by BioPharm International

Using a Systematic Approach for Selecting Critical Process Parameters for Process Control

Published by BioPharm International

Essentials in Establishing and Using a Product or Process Design Space

Published by BioPharm International

Essentials in Stability Analysis and Expiry Determination

Published by BioPharm International

Method Validation by Design to Support Formulation Development

Published by Pharmaceutical Technology (PharmTech)

Essentials in Quality Risk Management

Published by BioPharm International

Ten Requirements for Effective Process Control

Published by ASQ, Quality Progress