BUSINESS
BUSINESSGeneral Toxicity Studies
Test introduction
The general toxicity studies are the most fundamentasl asnd necessary tests in the registration/approval of newly developed substances such as medical supplies. health supplements, cosmetics, chemicals and pesticides. Throughout the procedure.
information regarding basic toxicity such as estimated fatal dose, No-Observed-Adverse-Effect Level(NOAEL) and the maximum tolerated dose is obtained, and the test results serves as the reference to other toxicity tests. Based on the duration of medication, there is either a single dose(acute) toxicity test, or repeated(sub-acute/chronic) toxicity test. In order to predict the early stage of toxicity, the dose range finding study, dose escalating study, and maximum tolerated dose finding study is performed.
Items of Trusted Research Evaluations((Applicable to ICH, OECD, JMHW, KFDA, NIER, RDA)
Single-dose toxicity test (Includes the maximum tolerated dose test)
The purpose of this test lies in figuring our the ALD, which stands for the approximate lethal dose in applying a single dose of test substances on rodents(rats/mice) and non-rodents(dogs, primates). The tes enables the evaluation of acute effects such as general symptoms during overdose, weigh and long-term effects of autopsy and provides very basic data for other tests such as repeated-dose toxicity test.
Repated-dose toxicity test
the test predicts the general toxicity during the time of repeated application for a certain period of time on rodents(rats.mice) and mon-rodents(dogs, primates). Its purpose is evaluating the relationship between the targe organs and dose-toxic effect to finde out it is NOEL or NOAEL throughout the general symptom observation, chang of weigh, consumption of food/water, ophthalmological examination, electrocardiogram, haematologica and blood biochemical test, and histopathological test.
Single dose / Repeated dose toxicity study
Single dose/Repeated dose toxicity study is performed considering injection time in clinical trials. Single dose study can be performed applying evaluated parameters and observation periods of repeated dose toxicity study.
세포치료제
- 단회/반복투여 독성시험
- 종양원성시험
- 세포잔존추적시험
Tumorigenicity study
To evaluate the tumorigenicity of the test substance, immunocompromised, immune-deficient or humanized animals are used to avoid xenograft rejection between test substance and test animals since the test substance is a human-derived cell. Tumorigenicity study is performed for 6 months which is a time period sufficient to observe for possibility of tumor formation
Detective study of residual cells
The objective of this study is to evaluate in vivo distribution, engraftment and proliferation in organs of cells for a sufficient period of time after injection of the test substance. Therefore, quantitative PCR analysis is performed.
Items of Other Trusted Research Test
- 01_ IRepeated dose test using infusion pump
- 02_ Transplantation test of tissue or internal organs
- 03_ Transplantation test of cell treatments