Preclinical Toxicology Testing Services | Toxicology Screening, Risk Assessment and Analysis

Developmental and Reproductive Toxicological Assessments

A fundamental part of preclinical research for large and small molecules that are geared for women of childbearing age or may be exposed to them during pregnancy is development and reproductive toxicology.

Toxikon’s study directors and scientists understand the challenges in reproductive safety posed by large and small molecule compounds. We have the capability to develop customized models for specific sponsor needs in identifying the effects caused by exposure to all types of pharmaceuticals and a variety of chemical substances on mammalian reproductive functions in all stages within the development process. At Toxikon we take pride in strict quality control for all of our testing services. Toxikon’s data evaluation process can also identify the potential risk of human exposure.

Specialty Studies

Our reproductive/developmental toxicology scientists can also optimize the objectives of any specific and cutting edge experimental design to integrate other scientific goals. We meet those goals by instituting a multidisciplinary project group. Preclinical project teams also conduct the following:

• Amniotic fluid and fetal blood collection

• Infusion exposure (continuous, intermittent or slow)

• Metabolism and pharmacokinetics

• Neurotoxicity and behavioral assessments

• Landmarks of development

Toxikon studies are conducted in accordance to the guidelines that have been adopted: FDA, MHLW, CPMP and the ICH/ harmonized tripartite guideline for the detection of toxicity to reproduction for all medicinal products.

OECD

 414 – Prenatal developmental toxicity

 415 – One generation reproduction toxicity

 416 – Two generation reproduction toxicity

 421 – Reproduction/developmental toxicity screening

 422 – Combined repeat dose toxicity with repro screening test

FDA

 Segment I – Reproduction toxicity

 Segment II – Teratology in rats

 Segment II – Teratology in rabbits

 Segment III – Perinatal toxicity

ICH

 Stage A – Premating to conception

 Stage B – Conception to implantation

 Stage C – Implantation to closure of hard palate

 Stage D – Closure of the hard palate to the end of pregnancy

 Stage E – Postnatal developing to weaning

 Stage F – Post weaning development of reproduction organs to puberty

Regulatory agencies utilize other guidelines, such as OPPTS (Office of Prevention, Pesticides and Toxic Substances). Toxikon conducts the following studies:

 870.3500 – Preliminary developmental toxicity screen

 870.3700 – Prenatal development toxicity study

 870.3800 – Reproduction and fertility effects

 870.6200 – Neurotoxicity screening battery

 870.6300 – Development neurotoxicity study