Developmental / Reproductive Toxicology Testing

Toxikon has a wide range of services and studies dedicated to this category. The main objective is to identify 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 our testing services. Toxikon's data evaluation process can allow us to identify the potential risk of human exposure.

Study capabilities and guidelines
Toxikon's programs are designed to achieve and impart basic study information based on -

• Probable use to which the drug is used in humans
• How the test samples are formulated and the administrative route
• Data on kinetics, pharmacodynamics, and toxicology
• Suitability of animal models

Studies performed at Toxikon Corporation are in accordance with the guidelines established by the regulatory agencies.

OECD

• 414 - Prenatal developmental toxicity
• 415 - One generation reproduction toxicity
• 416 - Two generation reproduction toxicity
• 421 - Reproductive/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 - Prenatal toxicity

ICH

• Stage A - Premating to conception
• Stage B - Conception to implantation
• Stage C - Implantation to closure of hard palate
• Stage D - Closure of hard palate to end of pregnancy
• Stage E - Postnatal developing to weaning
• Stage F - Post weaning development of reproductive organs to puberty

OPPTS

• 870.3500 - Preliminary developmental toxicity screening
• 870.3700 - Prenatal development toxicity study
• 870.3800 - Reproduction and fertility effects
• 870.6200 - Neurotoxicity screening battery
• 870.6300 - Developmental neurotoxicity study