Analytics

Andrew Feilden is the European E&L strategic director for Element.

Articles

A comprehensive understanding of potential material change can mitigate its impact on patient safety.

The Impact of Material Management on Extractables and Leachables

Gary Kruppa, PhD, is vice-president of Proteomics, Bruker Daltonics.

Innovations in single-cell analytics have advanced the progression of cell biology research, which has brought new understanding of disease mechanisms.

Single-Cell Proteomics Enable Advancements in Disease Research

Single-cell analytical technologies can deepen the understanding of cell biology and, therefore, disease mechanisms.

Innovations in Single-Cell Proteomics Drive Advances in Disease Research

By understanding potential material change, the impact on patient safety can be understood and mitigated.

Material Management and the Impact on Extractables and Leachables

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

Ashvin Patel, PhD, is the director of Analytical Research & Business Development, Teledyne Hanson Research, New York, USA.

This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.

IVPT Data Analysis with FDA Statistical Approach to Assess Bioequivalence

Editor of Pharmaceutical Technology Europe

Analyzing elemental impurities in drug products is—much like other analytical testing—primarily aimed at ensuring patient safety.

Ensuring Patient Safety Through Elemental Impurity Analysis

Grant Playter is the Assistant Editor for 

Dissolution testing has seen recent trends that have led to increased data integrity solutions as well as an increase in biorelevant testing techniques.

Dissolution Testing Sees Advances

Chris Spivey is the editorial director of 

FDA continues efforts to incentivize drug manufacturers to follow higher data integrity requirements.

Ensuring CGMP Standards for Data Integrity

Toby Blackburn is head of Business Development and Strategy at Emerald Cloud Lab.

The “cloud lab” is a virtual laboratory setting that can enable scientists to more quickly advance research.

Accelerating Scientific Research Using the Cloud

Marwan Alsarraj is the Biopharma Segment manager at Bio-Rad.

Using more exacting analytical tools can give a clearer assessment of gene-editing outcomes.

Analytical Method Development