Choosing the right excipient manufacturer can help ensure the use of quality excipients. How does one define quality as applied to excipients? If we pose the same question for APIs, the response would ...

This article discusses the role and importance of excipients in medicines, focusing on regulatory aspects crucial for pharmaceutical companies. The aim of the article is to provide an overview of ...

Excipients are crucial for addressing formulation challenges and optimizing oral solid dosage bioavailability in drug development. Advanced dosage forms, like 3D-printed tablets, require specialized ...

Pharmaceutical formulations consist of active pharmaceutical ingredients (APIs) and excipients. Appropriate excipient selection is critical to the final quality of pharmaceutical products. When ...

A culture of quality excipients has ushered in as the pharmaceutical industry advances towards manufacturing super and complex generics which requires high precision levels of process controls, Good ...

Welcome to the Journal of Regulatory Affairs, featuring in-depth coverage of the EU Artificial Intelligence Act (EU AI Act) as well as articles on engineering safety and effectiveness in drug-device ...

Inappropriate selection and control of excipients will lead to a critical situation (state of crisis). MIL-STD-1629A (US Dept Defense, 1980) uses the word ‘critical’ as a severity classification, one ...

The biologic excipients market has become a vital component of the pharmaceutical and biotechnology industries, playing a crucial role in the formulation of biologic drugs. These excipients are ...