Early Pharmacokinetics

Early pharmacokinetic studies provide valuable information about a drug's distribution or concentration in ocular tissues. 

Early pharmacokinetic (PK) studies provide valuable information about the penetration of a drug into the eye and its bioavailability in the target tissue, as well as how it is distributed through tissues of the eye. Data from this research are evaluated along with data from efficacy studies to guide future work. For pilot pharmacokinetic studies, Iris Pharma’s experienced and skilled staff can administer a drug in few animals, and perform microdissection and analysis of each structure of the eye to determine the PK profile and preliminary PK parameters such as Tmax, Cmax, half-life and area under the curve (AUC).

 

 

 

Preclinical Sample Analysis

As part of pilot pharmacokinetic studies, Iris Pharma can perform microdissection and sampling of each eye structure, including:

  • Cornea
  • Aqueous humor
  • Iris
  • Ciliary body
  • Lens
  • Vitreous
  • Retina
  • Choroid
  • Sclera
  • Optic nerve
  • Tears
  • Eyelid
  • Palpebral or bulbar conjunctiva
  • Nictitating membrane
  • Extraocular muscles
  • Lacrimal gland
  • Harderian gland
  • Nasolacrimal duct
  • Conjunctiva and subconjunctiva

 

 Iris Pharma is one of the only contract research organizations to have technicians trained to perform microsurgery to remove all of the delicate eye structures, and to offer routine bioanalytical testing in these structures.

 

 

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Simple Bioanalytical Methods

To support pilot pharmacokinetic studies, Iris Pharma’s bioanalytical team develops and validates a simple and fast method for quantifying the drug in the biological matrix of the eye using mass spectrometry (RRLC-MS/MS), chromatography (HPLC coupled with different detectors), immunoanalysis (EIA, RIA, and ELISA).

Bioanalytical Equipment

  • Hyphenated techniques: Triple-quadruple mass spectometer (RRLC-MS/MS)
  • Microsphere-based liquid array (Luminex Lx200): biochemical quantifications (e.g. cytokines in the in vivo model of endotoxin-induced uveitis) and multiple simultaneous analyses in low sample volumes
  • Chromatographic methods: High-performance liquid chromatography (HPLC) coupled with different detectors (MS, RID, FLUO, UV)
  • Ligand binding assays: enzyme-liked immunosorbent assay (ELISA), radioimmunoassay (RIA) and enzyme immunoassay (EIA)
  • Piccolo Xpress (Biochemistry analyzer)
  • Hematology analyzer