Ocular Center of Excellence
Ocular PK & Biodistribution
- Bioavailability, biodistribution, PK/PD
- Exploratory (non-GLP) or regulated (GLP)
- Single-dose or multiple-dose studies
- Animal biosafety levels 1 & 2
- Species: Rodent, Rabbits, Dogs, Pigs
- Test Articles: small & large molecules, chemicals, biologics (nucleic acids, peptides, proteins, antibodies, viral vectors etc.), devices
- Routes of Administration: topical, topical eyelid, intravitreal, intracameral, subretinal, surgical, oral gavage, intraperitoneal, intravenous
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Tissues
- Anterior Segment: aqueous humor, conjunctiva, cornea, lens, iris-ciliary body, trabecular meshwork
- Posterior Segment: retina, choroid, vitreous humor, sclera
- Other: tears, accessory glands (lacrimal, harderian, meibomian), optic nerve
- Non-ocular: blood, urine, CSF, feces, organs
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Bioanalysis
- Small & large molecule
- LC-MS/MS
- Immunoassay
- Analyses can be conducted following FDA GLP guidelines
- PK statistical analysis (WinNolin)
Toxicity
- Exploratory (non-GLP) or regulated (GLP)
- Species: Rodent, Rabbit, Dog, Pig
- Sub-acute, acute, chronic, dose response, tolerability, maximum tolerate dose
- Test articles: chemicals, biologics (nucleic acids, peptides, proteins, antibodies, viral vectors etc.), devices, drug delivery systems
- Routes of Administration: topical, topical eyelid, intravitreal, intracameral, subretinal, surgical, oral gavage, intraperitoneal, intravenous
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Readouts
- Ophthalmic Examination
- Intraocular Pressure
- Electroretinography
- Optical Coherence Tomography
- Histopathology
- Molecular Biomarkers (qPCR, Immunoassays, Western Blotting)
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In Vitro Toxicity Assays
- Viability
- Cytotoxicity
- Cell Signaling/Mechanism of Action
- Apoptosis
- Gene Expression
Efficacy Models
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Optic Nerve Crush
- Species: Mice
- Acute or chronic studies
- Single-dose or multiple-dose studies
- Test articles: chemicals or biologics (nucleic acids, peptides, proteins, antibodies)
- Routes of Administration: topical, topical eyelid, intravitreal, intracameral, oral gavage, intraperitoneal, intravenous
- Readouts
- Ophthalmic Examination
- Optical Coherence Tomography
- Electroretinography
- Histopathology
- Immunohistochemistry
- Molecular Biomarkers (qPCR, Immunoassays, Western Blotting)
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In Vitro Assays
- Cell Signaling/Pathway Activation
- Gene Expression
Capabilities
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Bioanalytical Detection
- Small and large molecules
- LC-MS/MS
- Immunoassays
- PK statistical analysis (WinNolin)
- Analyses can be conducted following FDA GLP guidelines
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Molecular Biomarkers/Biochemistry
- qPCR
- Immunoassays
- Western Blots
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Histology Services
- Paraffin, cryotomy, plastic
- Immunohistochemistry
- Special Stains
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In Vitro Assays
- Cell Signaling
- Gene Expression
- Viability
- Cytotoxicity
- Apoptosis
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In Vivo Imaging & Functional Assessments
- Optical Coherence Tomography
- Intraocular Pressure
- Electroretinography
- Fluorescein Angiography
- Ophthalmic Examination