Development and Reproductive Toxicology

Introduction

Development and reproductive toxicology focus on the effects of drugs on gonadal morphology and function, estrous cycle, mating behavior, conception, gestation process, delivery, lactation, and post-weaning growth and development of the pups. The complete drug non-clinical development and reproductive toxicity test consists of three phases:

• Fertility and early embryonic development (FEED) toxicity test
• Embryo-fetal developmental (EFD) toxicity test
• Pre- and Post-natal (PPND) toxicity test

Developmental and reproductive toxicity studies play an important role in limiting the scope of clinical study subjects and reducing the risk of drug use in clinical study subjects and in the post-marketing population.

Our Development and Reproductive Toxicology Services

• In vivo methods

Preclinical developmental and reproductive toxicology studies using mammalian research models provide important information on the effects of drug exposure before and during parental mating, as well as assessing maternal and fetal changes during pregnancy, the birthing process, and offspring development.

• Rodent single and multigenerational studies
• Multi-generation reproduction studies
• Juvenile animal testing to support safety evaluation of pediatric drugs 
• Neurobehavioral tests
• Growth development and reflex function testing

• In vitro methods

1. Short-term cellular assays to assess early differentiation stage toxicity
2. Perform cellular assays beyond 6 d to assess late stage differentiation toxicity
3. Zebrafish experiments
4. Rodent in vitro whole embryo culture (WEC) assay

If one of the above results is positive, the test compound is determined to be teratogenic or embryotoxic. If all of the above results are negative, the compound may be considered for no in vivo testing or only partial in vivo studies.

In vitro tests can be used to evaluate drug developmental and reproductive toxicity in vitro in an efficient and cost-effective manner, such as whole embryo culture (WEC), micromass culture (MM), embryo stem cell test (EST), zebrafish embryotoxicity assays, and CYP17 and CYP19 viability assays.

The development of a complete set of in vitro evaluation methods for reproductive and developmental toxicity is the key to make the prediction close to the in vivo assay results, and requires full consideration of somatic versus germ cells, species at different evolutionary stages, multiple reproductive toxicity cycles, and differences in metabolic activation in vivo and in vitro.

Why Choose BOC Sciences?

• Whole animal testing in non-clinical development and reproductive toxicology studies of drugs
• Adherence to the replacement, reduction and refinement (three Rs principle) for animal research
• Application of biomarkers for development and reproductive toxicology prediction of drugs based on expertise in genomics and proteomics
• Development of in vitro alternative method for development and reproductive toxicology and risk assessment models
• Combination of in vitro methods, quantitative conformational relationships (QSARs) and other alternative methods
• In vitro substitution experiments covering germ cells and somatic cells
• Drug non-clinical safety evaluation methods and experimental reports
• Toxicokinetic models accompanying each stage of reproductive development
• Compliance with FDA, EPA, ICH, OECD and CFDA
• All tests are conducted in compliance with Good Laboratory Practices (GLP)

What Can We Do?

Developmental and reproductive toxicology studies are an important component of drugs and chemicals safety evaluation. BOC Sciences' development and reproductive toxicology department has extensive experience in establishing a comprehensive system for evaluating non-clinical studies of drug reproduction and developmental toxicology. With years of accumulated historical control database, stable technology and professional research team, we provide high quality development and reproductive toxicology services.