Reproductive and Developmental toxicology

We have conducted an extensive number of projects in reproductive and developmental toxicology with pharmaceutical, veterinary pharmaceutical, chemical, agrochemical, food and consumer products. Together with comprehensive historical control databases, this extended experience allows our staff to conduct standard studies as well as highly specific custom projects.

Studies

Type

  • Study of Fertility and Early Embryonic Development to Implantation (ICH S5, segment I).
  • Study for effects on embryo-fetal development (ICH S5, segment II).
  • Study for effects on pre- and post-natal development, including maternal function (ICH segment III).
  • Multigeneration studies (OECD).
  • Juveniles studies.
  • Studies on sexually mature non-rodents with parameters of male or female reproductive functions (treatment at a specific time of the cycle possible).
  • Uterotrophic assays (juvenile or castrated)
  • Hershberger assays (juvenile or castrated).

 

Species:

Rodent and non-rodent species required by international guidelines. Historical data for different strains.

 

Routes of administration:

  • Oral: gavage, dietary admixtures, drinking water
  • Parenteral:

- Intravenous : bolus, slow injection, continuous infusion, cycles (vascular access port).

- Other routes : subcutaneous, intradermal, intramuscular, intraperitoneal

  • Dermal
  • Other routes: please consult


Specialty services

We offer a range of possible options that can be included in routine studies or in tailored studies, in order to meet specific needs.

 

  • Neurobehavioral testing:

- FOB

- Learning and memory: our state-of-the-art facilities and equipment include multiple T maze : 3T or 9T (Cincinnati water maze) and Moris water maze (circular pool of   water, no T)

  • Sperm analysis (rodent and non-rodents): including motility, morphology and concentration
  • Histopathology:

- Male reproductive organs including testicular staging

- Female reproductive organs including estrous cycle staging

  • Toxicokinetics, pharmacokinetics: parental blood samples, fetal tissues, fetal blood, amniotic fluid, milk.
  • Evaluation of effects on the skeleton: single or double staining, X-ray, DXA, pQCT, microCT, clinical chemistry, histomorphometry
  • Genomics: a large variety of tissues can be collected and analyzed (PCR, Affymetrix micro-chips)

 

Support services

  • Dedicated customized unit for the preparation of dosage forms
  • Analytical chemistry for dosage forms analysis (results obtained prior to administration)
  • Statistical analysis

 

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