GLP-like and GLP toxicity, tolerability, and PK studies

Summary: Small scale non-GLP toxicity and tolerability studies are a cost-effective approach to generate early data with your drug candidate.

Before you proceed with a complete GLP program for your drug candidate, consider running a small scale non-GLP toxicity and tolerability study. This is a more cost-effective approach specifically if no prior information is available.

The follow-up time might vary from 4 weeks to 3 months.

Routes of compound administration: topical, intravitreal, intracameral, subconjuctival, subretinal, systemic.

Outcomes and capabilities

Macroscopic and clinical examinations

We offer daily macroscopic examinations as well as weekly ophthalmic evaluation for any signs of irritation, inflammation in the anterior part of the eye as well as at the back side (e.g. Draize scoring).

Intraocular pressure assessment

Intraocular pressure is assessed in awake animals using TonoLab tonometer for rodents and TonoVet for rabbits (Kalesnykas & Uusitalo, 2007).

In vivo imaging

Our capabilities include fundus imaging, fluorescein angiography (Heidelberg Spectralis, Heidelberg Engineering), spectral-domain optical coherence tomography (SD-OCT, Envisu R2200 and R2210 systems, Bioptigen/Leica Microsystems), optical coherence tomography-angiography (OCT-A, Heidelberg Engineering).  

Functional evaluation

Electroretinography is used to assess functionality of retinal cells.

Tissue collection and pathological evaluation:

Blood (serum), aqueous humor, vitreous, and different parts of the eye can be collected for bioanalytical analysis.