Analytics

Feliza Mirasol is the science editor for 

Articles

Under the collaboration, Orionis will receive $47 million upfront to leverage its Allo-Glue platform to discover small-molecule monovalent glues.

Genentech Partners with Orionis Biosciences to Discover and Develop Molecular Glue Class Medicines

CN Bio and LifeNet Health LifeSciences have teamed up to provide direct access to a portfolio of highly characterized hepatic cells for the creation of advanced liver-on-a-chip assays.

CN Bio and LifeNet Health LifeSciences Partner to Supply Pre-Validated Cells

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.

Illumina Establishes New Center in India to Expand Genomics Capabilities

The focus in labs is leaning more heavily toward automated processes while at the same time maintaining efficiency, safety, and a personalized experience for the lab worker.

The Changing Analytical Landscape

Advanced analytical tools generate more data in today’s labs than ever before.

Dealing with Data: How to Keep It Manageable

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

Using Analytical Advancements to Assess Biosimilarity

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

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance

Sandbox AQ’s molecular simulation division is collaborating with companies like AstraZeneca and Sanofi to develop novel treatments for various disorders.

SandboxAQ Launches Molecular Simulation Division

E&L analytical testing methods can be determined through pointed consideration of the differences small- and large-molecule drug products.

E&L Analytical Testing Considerations

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

This paper demonstrates how assay data sets of a formulated liquid product, drug substance, and an impurity, obtained from combined accuracy-precision studies, are evaluated to calculate statistical intervals (prediction and tolerance intervals) and to graphically display the total analytical error (TAE) to account for the systematic and random errors. 

Analytical Method Development