At VxP Pharma, a complete range of toxicological services are available to support the ocular administration route in animal models, pre-clinical studies and/or clinical trials. Our toxicology team can provide extensive expertise with both large and small molecule drug candidates targeting the ocular space.
Specialized laboratory services are also available to meet your development needs for specific bioanalytical/TK research or safety studies. With a full scale bioanalytical laboratory and qualified toxicologists, we can support all stages of the drug development process in accordance with current Good Lab Practice (GLP) guidelines. We also have specific expertise in the LC-MS/MS bioanalysis of ocular drugs and related therapeutic molecules in the eye, throughout a variety of animal species.
- Compartmental and non-compartmental TK analysis
- Integration of TK and immunogenicity data
- Dose escalation and dose proportionality assessments
- Drug – drug interaction kinetics
- Repeat dose and assessment of steady state kinetics and linearity
- Guidance on preclinical – clinical allometric scaling
- TK study design, protocol writing and drug disposition
Ocular Bioanalysis and Histo-Prep
VxP has developed and validated multiple proprietary LC-MS/MS methods in a variety of ocular tissues and fluids throughout several animal species. These methods include the analysis of ocular tissue homogenates and direct measurement of intact processed tissues. Please contact us for more information.
Methods have been validated in the following ocular matrices:
- Aqueous Humor
- Ciliary Body
- Vitreous Humor
VxP Pharma offers rapid and dependable (GLP and Non-GLP) toxicokinetic analyses, interpretation and TK reporting of bioanalytical data generated from preclinical toxicology and drug metabolism studies. Our TK reports are specifically designed to meet client-specific formats, and will be comprehensively reviewed by our full service Quality Assurance Department.
Related TK Services
- Acute / Sub-chronic / Chronic Toxicology
- Dose Range Finding (DRF)
- Development & Reproductive Toxicology (DART)
- Dermal Toxicology
- Ocular/Ophthalmic Toxicology
- Pathology / Clinical Pathology
At VxP Pharma, we understand your needs and have the extensive experience working with the FDA, USDA, and EPA required to make your animal research projects a success. Specifically tailored, individual study designs enable our clients to meet their product development goals and facilitate world-wide regulatory approval. Our individualized approach to each study allows us to revise and shift directions based on your changing needs.
Our state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.