Developmental and Reproductive Toxicology

reproductive-and-developmental-cycle Inotiv supports DART and Juvenile animal studies (JAS) which are essential in identifying the potential risks of undesirable effects of your drug candidate, agrichemical product, or other chemical. Take advantage of our DART and JAS expertise in providing solutions that deliver the insights you need in program planning and individual study design in accordance with internationally recognized ICH and OECD guidelines. We provide a customized approach to meet your unique requirements as a complete in vivo integrated program or as a stand-alone service.

Gain the insight and expertise you need to progress to your next milestone with Inotiv’s DART and JAS service offerings

DART Services

CUSTOMIZED STUDY DESIGNS

Fertility and Early Embryonic Development studies for male and/or female (FEED, SEG I)
Embryo-Fetal Development/prenatal developmental toxicity studies (EFD, SEG II)
Pre- and Postnatal Developmental studies (PPND, SEG III)
Combined 28-day/reproduction screening (OECD 421/422)
Extended One-Generation Reproductive Toxicity studies (EOGRTS, OECD 443)

Male and Female Rat Pubertal Assays (USEPA Endocrine Disruptor Screening Program, OPPTS 890.1450/1500)
Rat Hershberger Assay (USEPA Endocrine Disruptor Screening Program, OPPTS 890.1400)
Rat Uterotrophic Assay (USEPA Endocrine Disruptor Screening Program, OPPTS 890.1600)

ROUTE OF ADMINISTRATION

Oral: Gavage, Dietary, Drinking Water
Subcutaneous
Intravenous
Intramuscular

JAS Services

CUSTOMIZED STUDY DESIGNS

Species selection and age for intended patient populations
Consideration of timing of dosing, exposure, monitoring, pharmacological/toxicological differences

ROUTE OF ADMINISTRATION

Oral Gavage
Subcutaneous
Intramuscular

SPECIES

Mouse
Rat

Behavioral Assessment Offering

LOCOMOTOR ACTIVITY

Models ability to navigate environment and habituation

STARTLE RESPONSE

Measures reflex due to a sudden stimulus for learning and habituation

MORRIS WATER MAZE

Studies spatial learning and memory

FUNCTIONAL OBSERVATIONAL BATTERY (FOB)

Detailed observation to detect changes in central nervous system, autonomic nervous system, and neuromuscular functions

In Vivo Services In Vivo Services From discovery to regulatory-enabling safety assessments in advanced developmental and reproductive toxicology (DART), we have the in vivo services and associated bioanalysis capabilities you need to find answers.

Drug Metabolism and Pharmacokinetics (DMPK) Drug Metabolism and Pharmacokinetics (DMPK) Whatever you need, from method development to metabolite ID, our phase-appropriate bioanalytical services help you analyze, answer, and advance.

Histology Histology Our industry-leading histology laboratories support your discovery and nonclinical development projects with a wide range of services. From tissue processing to digital analysis, our team delivers the quality you expect.

Pathology Pathology Access world-class anatomical, clinical, and medical device pathology services, from routine histochemistry, IHC, IF, and ISH to stereology.

Consulting Consulting

Our experts deliver the insights you deserve to get the answers you need, whether in DMPK data analysis, biomarker analysis, or bioequivalence studies.

DART Services

CUSTOMIZED STUDY DESIGNS

ROUTE OF ADMINISTRATION

JAS Services

CUSTOMIZED STUDY DESIGNS

ROUTE OF ADMINISTRATION

SPECIES

Behavioral Assessment Offering

LOCOMOTOR ACTIVITY

STARTLE RESPONSE

MORRIS WATER MAZE

FUNCTIONAL OBSERVATIONAL BATTERY (FOB)

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