ARTICLES BY RAJENDRAN (RAJ) ARUNAGIRI

• 8 Key Takeaways Of The Proposed FDA Modernization Act 3.0

  3/6/2024

  On Feb. 6, 2024, new legislation was introduced in the House of Representatives: the FDA Modernization Act 3.0. It aims to reduce and replace the use of animals in nonclinical research, improve predictivity of nonclinical testing, and potentially reduce drug development times. This article shares an overview. Note that the proposed legislation would still need to go through its course of passing the House and Senate and being signed by the president before becoming a law.

• 4 Strategies To Formulate Poorly Soluble APIs

  12/18/2023

  One of the toughest challenges facing small molecule drug development today is poor solubility of the API. No single technique has universal application, so several strategies exist. This article examines four notable strategies.

• Addressing 3 Challenges Of Developing Or Using A New Excipient

  5/8/2023

  As the world discovers new molecular entities, new solutions for and innovation of excipients are more critical than ever. However, they are often overlooked. Let’s look at how to address three key challenges: risk aversion, an inconsistent feedback loop between pharma companies and excipient suppliers, and the current lack of regulatory body-backed innovation programs.