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These models are useful in predicting whether an unknown substance of abuse can permeate the BBB to produce effects predicted by the Public Health Assessment via Structural Evaluation (PHASE) approach.

New QSAR Model for Predicting Blood Brain Barrier Permeability

The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.

FDA Publishes Draft Guidance on Statistical Approaches to Establishing Bioequivalence

Christopher Burgess, PhD, is managing director, Burgess Analytical Consultancy Limited, Barnard Castle, Co Durham, UK.

This article provides best practice to avoid errors in weighing by difference caused by buoyancy and drift.

Weighing Isn’t an Uncertain Process, Is It?

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Timothy Schofield is owner and consultant, CMC Sciences, LLC;

David Lansky, PhD, is president, Precision Bioassay, Inc.

A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality. 

Reducing Uncertainty of an Analytical Method through Efficient Use of Replication

Using the central limit theorem concerning the distribution of means allows one to justify the assumption of the normal distribution. 

Distribution of Data: The Central Limit Theorem

This article applies the basics of stability, performance, and capability to modern process performance and capability indices.

Process Stability, Performance, and Capability; What is the Difference?

Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446; chris@burgessconsultancy.com; www.burgessconsultancy.co

This article looks at a simple structured approach to assigning variance contributions and to assuring that the analytical procedure is fit for purpose.

Reportable Values: Where is the Variation Coming From?

Is there a difference between a specification and a standard?

Singlet Determination Revisited

A case study presents important lessons for using average and individual results, as well as user requirements, when qualifying a laboratory refrigerator. 


For Lab Equipment Qualification, Data Reveal Important Story

This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.


Statistical Solutions