Newsletter | February 16, 2023

02.16.23 -- FDA Adopts ICH Final Guidance On Bioanalytical Method Validation

Featured Editorial
Industry Insights
Is Your Sterile Injectable Ready For Changes In Raw Materials?

Changes in raw materials are inevitable over a drug's lifespan, but even small modifications can throw your drug out of compliance. Learn how to safeguard drug integrity when raw materials change.

Quality Matters: SEC Analysis For Antibody Aggregates

Size exclusion chromatography is the go-to analytical method for therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.

The Dynamic Regulatory Environment Of Drug-Device Combination Products
Examine the dynamic regulatory environment of drug-device combination products and learn concrete steps to take to navigate regulatory complexities and decrease time-to-market.
How To Use QbD Software To Improve An Existing Identification Method

What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a quality by design (QbD) approach.

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