Ocular Tissue Testing Services
Ocular Tissue Testing
Preclinical ocular tissue testing services are a critical phase in development and commercialization of new ophthalmic drugs and therapies. This process involves evaluating the safety, efficacy, and pharmacological properties of treatments using excised tissue in ex vivo and in vitro models.
Ex Vivo Permeation Testing
Ex vivo permeation testing of topical formulations across a biorelevant barrier (such as skin or ocular tissue) is vital to understand the rate and extent of permeation of an active ingredient. These studies help guide product development, including understanding the baseline permeability of the API in solution with and without excipients, formulation screening, and establishing the bioequivalence of a generic topical product to the Reference Listed Drug (RLD) product. The studies can be designed to accommodate the desired endpoints.
Using dermal tissue, rabbit cornea, and conjunctiva tissue, or 3D tissue barriers, ex vivo services can be utilized as an alternative to in vivo ocular testing, which involves clinical endpoints or pharmacokinetic studies.
Pharmaron has extensive experience conducting in vitro and ex vivo tissue permeation studies across various drug absorption barriers. For ocular drug delivery, we offer ex vivo rabbit and human cornea. Additionally, 3D tissue constructs are available to serve as another biorelevant barrier that performs consistently for head-to-head, high-throughput rank ordering in early topical development. Using these models, we can rapidly determine the permeability of test compounds across each of these barriers and/or test different formulations.
Capabilities
IVPT Bioequivalence Study Design:
- Optimization of study conditions: analytical, receiver buffer, time-point selection, and dose amount
- Establishment of sensitivity and selectivity for generic bioequivalence
- Qualification of the optimized assay parameters
- Validation: Analytical method validation and test system validation, including recovery, mass balance, and dose depletion
- Pivotal bioequivalence comparison with statistical evaluation: Parallel, single dose, and multiple donors
