Ocular Bioanalysis: Challenges and Advancements in Recent Years for These Rare Matrices

Abstract

There are many ocular diseases still presenting unmet medical needs. Therefore, new ophthalmologic drugs are being developed. Bioanalysis of eye compartments (along with plasma and other tissues) is important to determine exposure of the target organ to the drug and to help interpret local pharmacological or toxic effects. This review article identifies several challenges that occur within ocular bioanalysis. They include sample collection and preparation, analytical issues, sourcing control matrix, data interpretation and regulatory requirements. It summarizes how these challenges have been recently addressed, how research has advanced and which questions remain unanswered. Recommendations are made based on the literature and our practical experience within ocular bioanalysis and future perspectives are discussed.

Keywords::

• 3Rs
• fit for purpose validation
• ocular bioanalysis

Financial & competing interests disclosure

All authors are employed by F Hoffmann-La Roche Ltd. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Acknowledgements

The authors are thankful to F Bucheli, N Denk, P Dzygiel, L Ferrari, R Herisse, D Herzog, C Senn and S Zhou (F. Hoffmann-La Roche Ltd).