Analytics

Hanna Jankevics Jones, PhD, is a pharmaceutical segment marketing manager at Malvern Panalytical.

Natalia Markova is principal scientist, MicroCal, Malvern Instruments.

Articles

Using an orthogonal approach to lipid nanoparticle analysis can increase the odds of project success.

Shining a Light on Lipid Nanoparticle Characterization

It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.

Robust Bioanalytical Studies Can Aid in Regulatory Submissions

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

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

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

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

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 director of Industry Relations and Strategic Partnership, MJH Life Sciences.

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

Analytical Method Development