Consulting & communication ►

Consulting & communication ▼

▪ Strategic and global drug developm(...)

▪ Communication

Pre-clinical studies ►

Pre-clinical studies ▼

▪ Overview

▪ Pilot and proof of concept studies

▪ Ocular efficacy studies

Clinical trials ►

Clinical trials ▼

▪ Overview

▪ Phase I

▪ Phase II - III

▪ Audits

▪ Patient and Investigator recruitme(...)

▪ Project management

▪ Medical writing

R&D support services ►

R&D support services ▼

▪ Animal model development

▪ Ocular histopathology

Iris Pharma can perform the regulatory program (GLP, validated).

Prior to proof of concept or efficacy studies, Iris Pharma suggests to quickly evaluate (non-GLP) the ocular pharmacokinetics of your compound or formulation. Iris Pharma may also be able to help you discriminate several pre-clinical formulations.

OCULAR PHARMACOKINETICS STUDIES

Formulation: eyedrop, eyegel, ointment, insert, particle, implant, patch, microspheres, cream, …

Administration: topical ocular application, intravitreal injection (IVT), subconjunctival injection, subTenon injection (SBT), retrobulbar injection, periocular injection, intracameral injection, subretinal injection, intrascleral, transscleral, intrastromal, intravenous, intraperitoneal, intramuscular, iontophoresis …

Animals: rabbits, rats, guinea-pigs, mice (albino and pigmented)

Sampling:

• Microdissection: tears, eyelids, palpebral or bulbar conjunctiva, nictitating membrane, extra ocular muscles, lacrimal gland, Harderian gland, nasal lacrimal duct, cornea, aqueous humor, iris, ciliary body, lens, vitreous, retina (R), choroid (CH), sclera (SC), optic nerve, whole blood, plasma, urine, feces ...
• Autoradiograpgy : macro and micro

Detection:

• non radioactive: RRLC-MS/MS, LC-MS, HPLC-MS, HPLC UV, EC, refractometric and fluorescence detection, ELISA
• radioactive: ¹⁴C, ³H, ¹²⁵I, ⁵¹Cr

Parameters: Tmax, Cmax, AUC, % of applied dose, t½

Albino rat

Pigmented rat