Best of March: Top 5 Insights In Drug Formulation & Delivery

#1 - Subcutaneous Self-Administration: 3 Key Market Drivers, 3 Key Delivery Challenges

Discover the potential for subcutaneous delivery of drugs and biologics to advance and ease approaches to patient self-administration. Among the drivers and challenges are geriatric populations, chronic conditions, complex formulations, and drug delivery device selection.

#2 - Most Frequently Asked Questions On The Revised EU GMP Annex 1: Volume 1

The revised Good Manufacturing Practice (GMP) Annex 1 guidelines emphasize quality risk management, enhanced environmental monitoring, and data integrity, aiming to minimize contamination and ensure patient safety.

#3 - Combination Products: U.S. Vs. EU Requirements And A Harmonized Strategy To Prepare CTD Module 3

In the U.S. and the EU, there are differences in the terminology used for combination products, as well as in the format and location of the information in the dossiers. This article also proposes a harmonized approach for CTD Module 3.

#4 - Decoding the FDA Guidance on Essential Drug Delivery Outputs

To understand the guidance’s potential impact, it is necessary to explore the reasons behind the change as well as the document’s treatment of device development topics such as design outputs, verification/validation, and control strategy.

#5 - Growth And Advancements In Transdermal Drug Delivery

The transdermal drug delivery system industry is seeing significant growth. Let's look at new market research, including the advanced technologies being used and the therapeutic areas seeing the most impact.