reprotox

Reprotox

In accordance with the requirements of ICH M3 guideline on Guideline on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, evaluation of developmental and reproductive toxicology (DART) endpoints is a fundamental part of the non clinical safety assessment program for compounds with potential use for women of childbearing age or who might be exposed to them during pregnancy.

Our testing solutions ensure the practical implementation of ICH S5 (R2) guideline on Developmental and Reproductive Toxicity Testing for Pharmaceuticals and adequate study designs needed for registration of new medicinal products in member countries (European Union, Japan and the United States). You can rely on Vivotecnia to deliver timely nonclinical reproductive toxicology programs meeting your product development goals and facilitating your product registration.

Segment I: Fertility and Early Embryonic Development in Rat/Mouse

  • Fertility study in Female
  • Fertility study in Male
  • Combined fertility study in female and male

Segment II: Embryo Fetal Development in Rat/Mouse/rabbit

  • Preliminary dose-range embryo-fetal developmental studies
  • Definitive embryo-fetal development studies

Segment III: Prenatal and Postnatal Development in Rat/Mouse

  • Preliminary dose-range finding studies
  • Definitive Prenatal and Postnatal development studies
The ICH S5 guidelines (ICH, 2005) are now applied worldwide for the reproductive toxicity testing of new pharmaceuticals for reproductive and developmental toxicity (Barrow, 2009). These ICH study designs, however, are not applicable for the testing of vaccines.

In 2006, the CBER division of the FDA issued a guidance document on “Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications”, which gives specific recommendations on study designs and experimental methods (FDA, 2006a). This document is generally used today as the sole guideline for the design of non-clinical developmental studies for vaccines.

Models other than the rat, rabbit and nonhuman primate can be used to evaluate the effects of biotherapeutics in reproductive, developmental and juvenile toxicology studies
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Our team and Experience

Vivotecnia offers the high level of scientific expertise needed to address special DART regulatory studies requirements, including fertility, developmental toxicity (teratology), juvenile studies and multigenerational reproductive studies. Tests can be performed by using a variety of administration routes ranging from dermal to intravenous infusion. These designs are customized to individual Sponsor needs aligned with regulatory guidance, including FDA, EMEA, and OECD standards.

At Vivotecnia we are experienced and skilled in assessing all necessary endpoints:

Maternal evaluation

  • Necropsy
  • C-sections
  • Uterine examinations

Post-Life fetal evaluations in multiple species and strains

  • External morphology
  • Visceral
  • Skeletal

Neurobehavioral assessments

  • Motor activity
  • Learning
  • Memory
  • Acoustic startle response

Sperm assessments

  • Concentration
  • Count
  • Motility
  • Morphology
Methodology
  • Developmental and Reproductive Toxicity Testing for Pharmaceuticals:

    • Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 (R2).
    • The ICH S5(R2) Guideline for the Testing of Medicinal Agents:
      • Segment I: Fertility and Early Embryonic Development in Rat/Mouse
      • Segment II: Embryo Fetal Development in Rat/Mouse/rabbit
      • Segment III: Prenatal and Postnatal Development in Rat/Mouse
    • FDA Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications.
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