Sub-chronic Toxicity Study

With abundant experience in preclinical toxicity evaluation, Creative Biolabs is capable of providing integrated sub-chronic toxicity study service for worldwide customers. Our professional toxicologists enable us to conduct sub-chronic toxicity studies on numerous test substances which including but not limited to chemicals, traditional medicines, vaccines, and biological products. Importantly, we understand what you need and will try our best to satisfy every customer's requirements.

Objectives of Sub-chronic Toxicity Study

As a critical part of the preclinical study, sub-chronic toxicity study has long been used to determine crucial parameters for chronic toxicity study, which including but not limited to:

• Determine adverse effects not detected in short-term studies.
• Identify the observed effect of level & NOAEL.
• Provide data for dose selection for chronic toxicity.
• Identify the target organ/site of action.
• Data extrapolation to humans.
• Provide data for regulatory agencies.
• Provide risk assessment data.

Our Capabilities

As regulation required, a series of measures should be taken into consideration when a sub-chronic toxicity study is conducted. For example, test animals should be administered in the same routes of patients in clinical trials. The same dose of 0.9% normal saline should be administered to the control group over the test period. Moreover, animal weights and feed intake data should be recorded once a day. With years of experience in the field of toxicity and safety evaluation, our professional toxicologists can conduct multiple toxicity studies in compliance with GLP regulation. We understand your needs and have extensive experience working with the FDA, USDA, and EPA that is required to make your research projects a success.

The general design of sub-chronic toxicity that we provide:

• 25 animals per sex per group at 3 dose levels, a vehicle control group (40 animals)
• Study measurements include daily clinical observations, weekly body weights, and feed intake data
• Necropsy 20 animals at the completion of the dose period and place surviving animals into the recovery phase
• Necropsies are performed on any animals that die or upon termination; weights are recorded for major organs
• Target organs are examined in the intermediate groups
• Clinical observations: ophthalmological examination, hematology profiles, clinical chemistry tests, and urinalyses should be performed

Sub-chronic Toxicity Studies Available at Creative Biolabs

The rodent and non-rodent models of sub-chronic toxicity study we can provide include:

• 90-day sub-chronic toxicity study in rodents
• 90-day sub-chronic toxicity study in non-rodent
• 90-day sub-chronic inhalation toxicity study
• 90-day sub-chronic dermal toxicity study

You may also be interested in other general toxicity studies:

• Single Dose Study
• Repeat Dose Toxicity
• Acute Toxicity Study
• Sub-acute Toxicity Study
• Chronic Toxicity Study

Creative Biolabs is committed to providing integrated premier preclinical services for our global client's IND-enabling process development. With advanced technology, our experienced team consists of toxicologists, pathologists, veterinary surgeons, and regulatory specialists will feedback the data and outcome to you timely. Including sub-chronic toxicity service, we provide a comprehensive package of toxicity studies following as below.

For more detailed information, please feel free to contact us or directly sent us an inquiry. We are happy to work with worldwide customers to accelerate the development of their programs.

For Research Use Only.