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  4.  » Preclinical Toxicology vs Clinical: Key Considerations in Using Lipid-based Formulations

Preclinical Toxicology vs Clinical: Key Considerations in Using Lipid-based Formulations

Date: June 13, 2023 
Time: 11:00 am EDT 

Lipid-based formulation (LBF) can potentially improve the oral bioavailability of challenging molecules. However, when planning for solubility and bioavailability enhancement of poorly soluble drugs, LBF is often overlooked due to a generally poor understanding of LBF technology and the prevalence of preconceived notions about its complexity, especially when transitioning formulations from preclinical toxicology to clinical studies.

In this webinar, experts will offer insights into the perceived barriers to developing LBFs and recent advances in translating them into useful clinical and commercial products of lipophilic drugs. Experts will also discuss lipid excipients from the perspective of dosing in preclinical models for toxicology studies and their safety profile. In addition, the experts will discuss the preformulation considerations of LBF development and the use of PBPK modeling to yield key insights into oral bioavailability. Finally, experts will share approaches from an industrial standpoint on how to transition LBFs from preclinical toxicology to a viable formulation suitable for an accelerated pathway in the clinic.

Key Learning Objectives:

  • Discuss how lipid-based formulations impart their solubility-enabling benefits.
  • Understand the opportunities and limitations of using lipid-based formulations in preclinical toxicological studies.
  • Explore key considerations when transitioning enhanced formulations into the clinic.



Annette Müllertz, Ph.D. 
University of Copenhagen, Denmark


Grace Furman, Ph.D.
Paracelsus, Inc.


Lisa Caralli 
Senior Director, Scientific Advisory