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Toxicology Services
We’ve Got You Covered – from Formulation to Bioanalysis.
You can benefit from Absorption Systems’ integrated services for toxicology support. Preclinical toxicology and related safety studies are a pivotal part of the drug development life cycle as they are needed to demonstrate that the test compound is safe, and at what doses, for administration to humans as part of clinical trials.
Toxicology studies typically involve the use of a rodent species during the first assessments, followed by a move into a larger species such as a dog. Species selection is based on the models that are most representative of human, which is often determined by the test compound’s behavior in various in vitro preclinical and human matrices. Once the appropriate species are selected, maximum tolerated dose studies are performed in order to determine the dose ranges to be used for subsequent long-term toxicology studies. These long-term toxicology studies are one of the most critical steps in drug development as they ensure the safety of the test compound for the duration of any clinical trials.
Toxicology models focus on determining the maximum tolerated dose and the toxicities associated with sub-chronic and chronic dosing of a given drug.
Our formulations team can help identify and prepare dose vehicles that are appropriate for short or long-term toxicology studies. Dosing and observations are handled by our expert staff with more than a decade’s experience in small and large animal studies (acute, subchronic, chronic, dose range finding, etc). Our in-house bioanlaytical capabilities (both non-GLP and GLP) enable us to oversee your project from beginning to end.
Toxicology models include small and large animal species, as well as a comprehensive portfolio of dose routes.
Our vivarium is AAALAC-accredited, registered by USDA and NIH, and inspected by FDA. We house dedicated colonies of dogs and pigs, and can handle just about any small or large animal species. Our San Diego facility is also equipped with a state-of-the art surgery suite complete with pre/post operation room and necropsy room. You can even get live feedback from streaming video in the observation room.
| Species include: Rats Mice Guinea Pigs Rabbits Dogs Monkeys Pigs and Mini-pigs Sheep Goats |
Dose routes include but are not limited to: |
Toxicology IND Tabbed Module
EA601 Non-GLP Acute Toxicity in Mice (dose range finding - single dose MTD)
EA602 Non-GLP Maximum Tolerated Dose in Mice (dose range finding - single and repeat dose MTD)
EA603 GLP Tox 7-day Repeat Dosing in Mice
EA604 GLP Tox 14-day Repeat Dosing in Mice
EA605 GLP Tox 8-day Repeat Dosing in Mice
EA606 Non-GLP Acute Toxicity in Rats (dose range finding - single dose MTD)
EA607 Non-GLP Maximum Tolerated Dose in Rats (dose range finding - single and repeat dose MTD)
EA608 GLP Tox 7-day Repeat Dosing in Rats
EA609 GLP Tox 14-day Repeat Dosing in Rats
EA610 GLP Tox 28-day Repeat Dosing in Rats
EA611 Non-GLP Acute Toxicity in Dogs (dose range finding - single dose MTD)
EA612 Non-GLP Maximum Tolerated Dose in Dogs (dose range finding - single and repeat dose MTD)
EA613 GLP Tox 7-day Repeat Dosing in Dogs
EA614 GLP Tox 14-day Repeat Dosing in Dogs
EA615 GLP Tox 28-day Repeat Dosing in Dogs
Toxicology studies involve the administration of test compound to animals, typically, though not always, over the course of several days to weeks. Animals are monitored daily for signs of distress, morbidity and mortality. At the end of the study, the animals undergo a necropsy with macroscopic observations. An extensive list of tissues is collected from the animals and clinical pathology and histopathology are performed. In studies where toxicokinetics are also being evaluated, blood samples are obtained from parallel groups of animals at different time points. Plasma is prepared and subjected to bioanalysis by LC-MS/MS.
| EA180 Cytotoxicity Caco-2 EA181 HepG2 Cell Cytotoxicity EA182 Hepatocyte Cytotoxicity EA190 Hemolysis EA401 Express MS - HLM EA402 Express MS - RLM EA403 MS - Liver Microsomes EA404 MS - S9 EA405 MS - Hepatocytes EA412 Metabolite Id EA415 Express MS - MLM EA416 Express MS - PLM EA417 Express MS - DLM EA419 Biomimetic Oxidation EA438 Metab ID w/out struct eluc EA439 Metab ID with struct eluc EA436 Screening Met ID w/out structure assignment EA437 Screening Met ID with structure assignment EA801 Rat PK EA802 Brain to Plasma Ratio - Rat |
EA804 Mouse PK EA805 Dog PK EA806 Monkey PK EA807 Express Mouse PK EA808 Express Rat PK EA809 Minipig PK EA810 Express Dog PK Crossover EA812 Express Dog PK Noncrossover EA813 Express ABT Rat PK EA820 Express Rodent Brain to Plasma Ratio EA821 Express Rabbit PK EA822 Absolute Bilavailability in Rabbits EA949 Bioanalytical non-GLP Preclinical EA950 Bioanalytical-GLP Preclinical EA951 Bioanalytical NonGLP Clinical EA952 Bioanalytical GLP Clinical EA960 Toxicology Bioanalytical Non-GLP EA961 Toxicology Bioanalytical GLP EA982 Express Formulation Assessment EA990 Vivarium Leasing |
How should I design my study?
The study should be designed by a professional toxicologist with extensive experience in the therapeutic area that your compound is targeting, such as metabolic disease, cancer, etc. Absorption Systems can help you with the design or we can prepare a quote based on a design provided by the sponsor. In addition, we strongly recommend having the preliminary design reviewed by the regulatory agency or by consultants thoroughly knowledgeable about the regulatory requirement in your therapeutic area.
What species should I use for toxicity testing?
The broad recommendations suggest 1 rodent and 1 non-rodent species for safety testing and rodents for reproductive and carcinogenicity studies. The choice of non-rodent species is critical and should be based on historical knowledge of the animals' normal physiology, its metabolism of the compound under study and known hypersenitivies to similar compounds. Absorption Systems scientists can help you in all these areas.
I have a combination of a drug and a device. How do I design a toxicology study?
Absorption Systems' San Diego facility specializes in these types of studies, contact us to discuss your project.
Board-certified toxicologists, veterinarians, and experienced technicians are on staff, supported by formulation development and GLP bioanalysis of toxicokinetic samples, for in-depth investigation of drug safety. Our site is AAALAC accredited, USDA registered, NIH assured, and FDA-inspected.
We can perform bioanalysis and formulation development in-house to complement your toxicology studies.
Minimal lead time to study initiation – local animal vendors
Experience with various dose routes including ocular