reprotox

Reprotox Studies

As stipulated in ICH guideline M3(R2) Guidance 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 nonclinical safety assessment program for any compounds which women of childbearing age might use or be exposed to during pregnancy.

Our testing solutions ensure the practical implementation of ICH guideline S5(R2) and appropriate study designs necessary for registering 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 to meet your product development goals and facilitate your product registration.

Segment I: Fertility and early embryonic development in rat/mouse

  • Female fertility study
  • Male fertility study
  • Combined female and male fertility studies

Segment II: Embryofetal development in rat/mouse/rabbit

  • Preliminary dose-range-finding embryofetal developmental studies
  • Definitive embryofetal developmental studies

Segment III: Prenatal and postnatal development in rat/mouse

  • Preliminary dose-range-finding studies
  • Definitive prenatal and postnatal development studies
The ICH reproductive toxicity guidelines (S5(R2) 2005) are now applied worldwide for reproductive and developmental toxicity testing of new pharmaceuticals (Barrow, Reprod Toxicol. 2009 Sep;28(2):172-9). These ICH study designs, however, are not applicable for testing vaccines.

In 2006, the CBER division of the FDA issued a guidance document “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 practically the sole guideline used today for designing nonclinical 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 study requirements, including fertility, developmental toxicity (teratology), juvenile studies and multigenerational reproductive studies. Tests can be performed using a wide selection of administration routes, for example dermal or intravenous infusion. Our designs are customized to individual sponsor needs in line with regulatory guidances, encompassing 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-mortem fetal evaluations in multiple species and strains

  • External morphology
  • Visceral
  • Skeletal

Neurobehavioral assessments

  • Motor activity
  • Learning
  • Memory
  • Acoustic startle response

Sperm evaluation

  • 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, ICH M3(R2), June 2009
  • Detection of toxicity to reproduction for medicinal products & toxicity to male fertility, ICH S5(R2), November 2005
    • Segment I: Fertility and early embryonic development in rat/mouse
    • Segment II: Embryofetal development in rat/mouse/rabbit
    • Segment III: Prenatal and postnatal development in rat/mouse
  • FDA Guidance for industry on considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications, February 2006
reprotox

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