Advanced deformulation for complex generic development

Developing complex generic products requires a detailed understanding of the reference product. As formulations become more complex and regulatory expectations evolve, deformulation can help establish the qualitative, quantitative and, where relevant, microstructural characteristics needed to support development. 
In this white paper, we explore how advanced analytical techniques can be used to characterise complex reference products, identify and quantify challenging excipients and reduce development uncertainty. The paper also looks at how deformulation can support formulation development, bioequivalence readiness and filing.  

Key takeaways  

• Understand the role of deformulation in complex generic development 
• Explore approaches to excipient identification and quantification 
• See how analytical characterisation can help reduce development uncertainty 
• Understand how deformulation can help reduce formulation iterations 
• Explore how deformulation can support bioequivalence and filing readiness 
• See practical examples involving polymers, magnesium stearate and sodium starch glycolate  

Fill out the short form to access the whitepaper that explores the analytical approaches used in advanced deformulation and how they can support complex generic development.