Pharmaceutical Technology, February 2024

Steffen Thirstrup, chief medical officer at the European Medicines Agency, provides insight on regulatory challenges in Europe.

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

This article introduces that the basic technique for tolerance interval is implemented using the conventional range 85–115% LC where the proposed range in the PF is not taken into account.

Continuous manufacturing and a quality-by-design development approach are a natural fit.

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

Effective analytics will eliminate failures, deviations, and non-conformances.

Strategizing a PK/PD study approach in early phase development facilitates a successful clinical progression.

The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.

The industry’s M&A activity is on the up and expected to continue to rise in 2024.

Given its positioning at each new year’s commencement, the J.P. Morgan Healthcare conference helps establish the tone with which the pharmaceutical industry is viewed.

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Designed for processing high viscosity dispersions and suspensions, the ROSS line of Dual-Shaft Mixers are versatile systems utilized in the chemical, pharmaceutical, food, cosmetic, adhesive, coating, composite, and other industries.

Distek’s software update for the Opt-Diss–In-Situ Fiber Optic UV System for Dissolution Testing, Version 3.20, introduces enhancements designed to streamline the dissolution testing process and expand the system’s capabilities.