Toxikon is a leading preclinical contract research organization (CRO) providing in vivo, in vitro, and analytical testing services for the pharmaceutical, biotechnology, and medical device industries – helping those companies gain approval for their products quickly and bring them to market successfully. We are proud to play a vital and singular role in the chain of events that move innovative therapies from concept, through research and development, into trials and approvals, through production and commercialization, and finally delivered to the consumer. We care about your products – and the life-changing outcomes they can offer – as much as you do. With over 40 years of broad and deep experience in navigating the dynamic regulatory landscape, we have the expertise and technical skill to supply you with the results you need to gain approval for your products, demonstrating safety and efficacy.
Toxikon provides full testing support for the ISO 10993 guidance.
With a strong foundation in toxicology and biocompatibility, our custom device testing capabilities include:
As a multidisciplinary contract research organization, Toxikon is focused on evaluating the safety and toxicity of biologics, pharmaceuticals and medical devices. One of Toxikon’s specialties is conducting studies focused on the treatment of ocular diseases. Our experienced study directors will provide you with the expertise in ophthalmology models and endpoints for your ocular drug program.
Ophthalmic Development Capabilities:
While our reputation has been built on our vast toxicology and chemistry experience,Toxikon’s Ocular Program capabilities include:
These studies in small and large animal models, include acute irritation, ocular distribution (PK/PD), acute and repeat dose toxicity, implantation, drug screening and drug efficacy. We can also customize studies for targeted therapeutics, such as dry eye and corneal wound healing, inflammation and uveitis, neovascularization and age-related macular degeneration, glaucoma and neuroprotection.
As part of our extensive custom research and testing portfolio for ophthalmic drug discovery, we offer a variety of preclinical services, including the screening of neuroprotective compounds and creation of animal models for glaucoma research. Our scientists are experts in the field, and their work is published widely. We invite you to speak with them at upcoming conferences and to see samples of their work.
The goal of in vivo testing medical devices is to determine the safety or biocompatibility of the device in a biological environment. Toxikon can design a study that is specific to determining the ability of a medical device to perform with an appropriate host response in a given application. Our In Vivo Department study directors will work closely with you to design biocompatibility assessments to measure the magnitude and duration of alterations in homeostatic mechanisms, favorable and adverse, in determining host response.
Some of the services for medical device development that Toxikon offers are:
Other tests: Sensitization, intracutaneous irritation, acute systemic toxicity, subchronic toxicity, implantation, hemocompatibility, and carcinogenicity.
Experience performing both short term and long term ocular studies
Studies typically cover conjunctiva, cornea, lens, fundus, choroid, and optic nerve
Studies performed by in-house ophthalmologist with experience performing ocular implants
Ocular Examinations include:
•Anterior segment of the eye•Slit-Lamp; Draizeand McDonald-Shadduckscoring systems
•Posterior segment of eye
•Direct & Indirect ophthalmoscopy
Biocompatibility testing of materials and packaging.
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