GLP Ocular Pharmacokinetics

We perform pharmacokinetic and toxicokinetic evaluations in a Good Laboratory Practice (GLP) environment.

Pharmacokinetic (PK) and toxicokinetic (TK) analyses provide information that can guide the selection of dose levels and administration frequency for future animal and clinical studies. Iris Pharma offers complete ocular PK and TK evaluation services in a Good Laboratory Practice (GLP) environment, which allows us to obtain reliable data that is required before first-in-human and phase I clinical studies of your product. 

 

 

Pharmacokinetics

Iris Pharma performs ocular pharmacokinetics studies, including: 

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: 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, tears, eyelids
  • Whole blood, plasma, urine, feces ...
  • Autoradiograpgy: macro and micro

Detection:

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

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

eye structure

Toxicokinetics

Toxicokinetic endpoints are similar to those used for pharmacokinetics, except that samples are collected during toxicology and safety studies. These results help us understand a drug's behavior at the maximal dose used in toxicology studies, and provide steady state, accumulation, and trough levels after repeated administration.

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Analytical Method Validation

Iris Pharma has been a Good Laboratory Practice (GLP)-compliant bioanalytical laboratory since 1995, and we conduct validations and study sample analyses that meet recognized international guidelines, including those issued by the United States Food and Drug Administration (FDA), the International Conference on Harmonisation (ICH), and the Organization for Economic Co-operation and Development (OECD).

Iris Pharma develops, customizes, and validates assays of drug candidates and metabolites in a variety of ocular matrices to support preclinical, biopharmaceutical, and clinical pharmacology programs.

We are experts in processing samples using tools that are both fast and sensitive, such as:

  • Triple-quadruple mass systems (RRLC-MS/MS)
  • High-performance liquid chromatography coupled with different detectors (MS, RID, FLUO, UV)
  • Immunoanalysis (EIA-RIA-ELISA measurement)
  • Radioactivity counters (beta and gamma)

 

Ocular Matrices

Iris Pharma offers routine bioanalytical testing in multiple biological species and rare ocular matrices.

 

The primary matrices used at Iris Pharma include: 

Tears
Ciliary body
Palpebral Conjunctiva
Vitreous
Bulbar Conjunctiva
Retina
Aqueous Humor
Choroid
Cornea
Sclera
Lens
Optic nerve
Iris
Plasma and Blood

 

Techniques & Equipment

Bioanalytical Techniques and Equipment

We are experts in processing samples using tools that are both fast and sensitive, such as:

  • Hyphenated techniques: Triple-quadrupole 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),
  • Radioactivity counter (beta and gamma),
  • Piccolo Xpress (Biochemistry analyzer),
  • MS9-5 (Hematology analyzer).