The Study of Drug Reproductive Toxicity Test
Medicine is a double-edged sword. It can not only cure diseases and save people but also produce adverse reactions that damage human health.
Reproductive toxicity research is one of the essential contents of drug toxicity research, which refers to the damage of drugs to reproductive function and ability and the unfavorable mailbox for offspring. For drugs to be used in humans, animal reproductive toxicity tests need to be comprehensively considered based on the intended indications and characteristics of the test substance.
We boast professional teams and practical experience in drug safety evaluation and can promise high-quality data and fast turnaround time to support various drug safety evaluation. Our toxicology research can be carried out according to non-GLP or GLP standards. Our research platform has been rated as Shanghai R&D Public Service Platform.
Failure of a compound at the Clinical stage is very costly, and considerable efforts are made to eliminate potentially toxic compounds much earlier in the drug discovery process using in vitro, or even in silico methods.
Understanding the reproductive toxicity of drugs is very important for guiding the safety of the clinical medication. The reproductive toxicity of drugs has two characteristics: sensitivity to the toxic effects of drugs at a specific dose, before damage to other systems, occurs, a particular part of the reproductive process may have been damaged; the reproductive toxicity of drugs is not only manifested in the exposure of drugs The body itself can also affect offspring. Therefore, reproductive toxicity can occur both during pregnancy and during pregnancy and lactation. The drug reproductive toxicity test should implement GLP specifications. There are many research methods for the reproductive and developmental toxicity of drugs. Commonly used reproductive toxicity test programs include the following three parts of joint research:
(1) Segment Ⅰ (fertility and early embryo development):
Also called the general reproductive toxicity test studies the effects of drugs on the entire reproductive process. It evaluates whether germ cells adversely affect conception ability, reproductive system, and offspring after drug exposure. At least one animal is used in selecting experimental animals, and rats are the first choice. Fertility and early embryo developmental toxicity tests are an essential part of drug reproductive toxicity research, and they are also indispensable in developing innovative drugs. The staff of Medicilon’s reproductive toxicity research service platform is composed of a professional technical team led by senior domestic reproductive toxicity experts with 30 years of research experience; the animal laboratory was jointly established by Medicilon and MPI Research (American Toxicology Research Company), Passed the International Laboratory Animal Assessment and Approval (AAALAC) and reached the GLP dual standards of FDA and CFDA.
(2) Segment Ⅱ (embryo-fetal development):
The purpose is to assess the harmful effects of exposure to the test substance from the blastocyst implantation to the closure of the hard palate (the organogenesis period) on pregnant females and the development of the embryo-fetal body. The consequences of embryo-fetal developmental toxicity are relatively more severe, and we should pay more attention to the results of this test section. If a variety of animals are used for testing, it may provide an adequate test basis when the test results are extrapolated to humans. The test usually uses two animals, one is a rodent, and rats are recommended, and the other is a non-rodent, and rabbits are recommended.
(3) Segment Ⅲ (developmental toxicity test before and after birth)
Perinatal toxicity test to evaluate the effects of drugs on the growth and development of fetuses after birth, to detect the adverse effects of drug administration on pregnant/lactating females, and the development of embryos and offspring from embryo implantation to pup weaning. At least one animal is used in the selection of experimental animals, and rats recommend.
My country’s reproductive toxicity research of innovative drugs adopts the conventional three-stage test design. The current reproductive toxicity test research of drugs divides into the above three-stage. When adopting the segmented test design, pay attention to the animal’s adulthood from conception to pregnancy. The pups are administered at all stages of sexual maturity. The observation should continue for a complete life cycle (from the beginning of one generation to the next). In actual operation, a single (entire course) test design and a two-stage test design can be used for rodents according to the test substance’s indications and characteristics.
In the study of reproductive drug toxicity, other test schemes can also be considered comprehensively according to the characteristics of the test substance, intended indications, and clinical medication.
