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Pharmaceutical Technology, February 2024
European Medicines Agency Viewpoint
February 17, 2024
Quality/Regulations
48
2
Steffen Thirstrup, chief medical officer at the European Medicines Agency, provides insight on regulatory challenges in Europe.
Emerging Therapies Drive Analytical Advancements
February 03, 2024
Cover Story
48
2
The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.
Using Tolerance Intervals for Evaluation of Uniformity of Dosage Units Data in Routine Batch Release
February 03, 2024
Peer-Reviewed
48
2
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.
QbD for Small-Molecule Continuous Process Development
February 03, 2024
Development
48
2
Continuous manufacturing and a quality-by-design development approach are a natural fit.
Compounding Overview: Primary Considerations for the Workplace
February 03, 2024
Manufacturing
48
2
Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.
Analyzing Exabytes
February 02, 2024
Analytics
48
2
Effective analytics will eliminate failures, deviations, and non-conformances.
Addressing PK/PD Study Design Early in Development
February 02, 2024
Outsourcing
48
2
Strategizing a PK/PD study approach in early phase development facilitates a successful clinical progression.
MHRA’s New International Recognition Procedure
February 02, 2024
Regulatory Watch
48
2
The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.
On the Up and Up
February 02, 2024
From The Editor
48
2
The industry’s M&A activity is on the up and expected to continue to rise in 2024.
J.P. Morgan Losing Weight
February 02, 2024
From the CEO
48
2
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.
Computer Validation Confirms Evidence
February 02, 2024
Ask the Expert
48
2
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
ROSS Dual-Shaft Mixers
February 02, 2024
Product Spotlight
48
2
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.
Dissolution Testing Software
February 02, 2024
Product Spotlight
48
2
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.