Best of May: Top 5 Insights In Drug Formulation and Delivery

#1 - Long Live Design Controls: Navigating The Shift From QSR To QMSR

The transition to a Quality Management System Regulation (QMSR) has effectively superseded the explicit medical device design controls CFRs and associated FDA guidance, though their essence lives on.

#2 - BD Innovation For Subcutaneous Delivery Of Large-Volume Complex Biologics

Explore the key findings of a new wearable injector clinical trial, including its positive impact on patient experience and the broader benefits of wearable injectors for chronic disease management.

#3 - Innovating Bioequivalence: A Novel Approach To Developing Complex Generic Dosage Forms

Achieving bioequivalence for complex generics is an intricate task. This article describes an approach using in vitro–in vivo correlation, PBMK modeling, and more.

#4 - Improve The Bioavailability Of Poorly Soluble Drugs: KinetiSol™ Technology

KinetiSol is a fusion-based, solvent-free process that utilizes frictional and shear energies - in a fraction of the time of other amorphous solid dispersion technologies.

#5 - Organizational Imperatives For Combination Product Development

Developers of combination products must address varied and numerous regulatory stipulations and considerations. In this article, drug delivery industry veteran Fran DeGrazio offers recommendations for how to do so efficiently and effectively.