New Jersey, September 23, 2021- Freyr, a leading global Regulatory solutions and services provider, is pleased to announce the feat of completing 40+ Permitted Daily Exposure (PDE) reports for a multi-national pharmaceutical company’s Ophthalmic and Otic products.

The development of PDE/ADE for ophthalmic and otic drug products is unique and requires a different approach. Unlike other pharmaceutical compounds there is paucity of nonclinical data including clinical doses and pharmacokinetics. The ADME considerations in the overall assessment play an important role. Therefore, derivation of ADE/PDE values for Ophthalmic or Otic products requires sound knowledge and understanding of the ADME with application of principles of toxicological risk assessment approaches to effectively communicate the appropriate risk.

Freyr developed and delivered high-quality PDE/ADE reports despite several challenges like availability of very limited or no toxicology/safety data, use of read across strategy and other considerations like extrapolation to other routes of exposures without sufficient pharmacokinetic information.