Newsletter | July 22, 2020

07.22.20 -- A Strategic Approach To Efficient Drug Development

 
Strategies For API Solubility And Bioavailability Enhancement: Selecting Technologies And Excipients
 

Bypassing conventional trial-and-error methods for solubility challenges and excipient selection can eliminate unnecessary testing, improve the efficacy of your formulation, and increase your overall speed-to-market.

Quality By Design: A Holistic Approach To Drug Development
 

As the biopharmaceutical industry continues to evolve, the quality by design (QbD) holistic and proactive approach to drug development and manufacturing is transforming key processes. While QbD evolves from good practices to agency requirements, how can sponsors ensure that rigorous, scientific risk-based approaches are used to bring better and safer therapies to market faster?

Broaden Analysis Of Compound Factors For Predictive Solubility Solutions
 

Developed by the FDA, the Biopharmaceutics Classification System (BCS) helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. The objective of the BCS system is to predict in vivo performance of drugs from in vitro measurements of solubility and permeability.

Ensuring The Greatest Return From Your Poorly Soluble Molecule
 

Currently, about 70 percent of new molecular entities exhibit poor solubility in water and require some form of enhancement in order to achieve sufficient bioavailability. However, the sheer number of potential strategies for improving the solubility of a compound can overwhelm many developers, leaving them unsure how to choose a path forward.