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Overview
Reproductive toxicology is the study of how pharmaceuticals and other substances impact mammalian reproductive functions, as well as embryonic and fetal development. Reproductive toxicology research is essential before a drug can be approved for clinical use. Through animal testing, researchers can predict not only the possible adverse effects of a substance on reproductive cells, fertility, pregnancy, delivery, lactation, and other parental reproductive functions, but also the possible adverse effects of the substance on embryo-fetal development and post-natal development. Our company offers flexible solutions for conducting various stages of reproductive studies to ensure the safety and efficacy of pharmaceuticals for clinical use.
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Segment I Reproductive Toxicity Test
- Purpose: This test focuses on fertility and early embryonic development toxicity, also known as general reproductive toxicity test. It evaluates the impact of a drug on fertility and early embryo development.
- Administration Period: The administration period starts from pre-mating to implantation, covering the crucial stages of reproductive activity.
- Toxicity Assessment Content: Focuses on general maternal and paternal toxicity, fertility, and toxicity related to early embryonic development, such as embryo death.
Segment II Reproductive Toxicity Test
- Purpose: This test focuses on embryo-fetal development toxicity, also known as the teratogenic sensitive period toxicity test. It aims to reveal the potential embryo-fetal toxicity and teratogenicity of drugs.
- Administration Period: The test article is administered during organogenesis, which is the period of organ formation in the developing fetus.
- Toxicity Assessment Content: Includes assessment of general maternal toxicity, embryo-fetal developmental toxicity (such as death, malformation, and developmental abnormalities).
Segment III Reproductive Toxicity Test
- Purpose: This test assesses pre-natal and post-natal reproductive toxicity. Drugs are administered during the perinatal and lactation periods to observe their effects on the growth and development of offspring after birth.
- Administration Period: The drug is administered during pregnancy and lactation.
- Toxicity Assessment Content: Focuses on general maternal toxicity, delivery, lactation, and offspring developmental toxicity, including death, malformation, developmental abnormalities, and functional toxicity.
Frequently Asked Questions (FAQs) About Reproductive Toxicology
How are reproductive toxicology studies conducted?
Reproductive toxicology studies are typically conducted using animal models such as rats, mice, rabbits, and non-human primates. The studies involve administering the test substance to animals at various doses and observing reproductive outcomes over multiple generations. Data collection includes monitoring fertility, mating behavior, pregnancy outcomes, embryo-fetal development, postnatal growth, and development.
What are the long-term implications of reproductive toxicity?
The long-term implications of reproductive toxicity can include reduced fertility, increased risk of miscarriage and stillbirth, birth defects, developmental disabilities, and chronic health problems in offspring. Additionally, exposure to reproductive toxicants may have intergenerational effects, affecting future generations' reproductive health and overall well-being. Therefore, the identification and mitigation of reproductive hazards is essential to promote population health and the sustainability of ecosystems.
What are No Observed Adverse Effect Level (NOAEL) and Lowest Observed Adverse Effect Level (LOAEL)?
NOAEL: The highest tested dose of a substance at which no adverse effects on reproductive or developmental processes were observed.
LOAEL: The lowest tested dose of a substance at which adverse effects on reproductive or developmental processes were observed.