Safety Assessment / Toxicology
Our spectrum of non-GLP and GLP service offerings along with our experience of over 3 decades, ensures that we meet all the current global safety testing requirements. Eurofins’ experienced CDMO team project manages and works seamlessly to enable timely completion of all studies in the package to expedite regulatory submissions.
Eurofins CDMO (Contract Development & Manufacturing Organization) offers full IND-enabling CMC and PharmTox packages. We also offer capabilities for production of cGMP material for your early clinical development, late clinical development (for niche molecules), and long term non-clinical safety studies for NDA submission (see below).
We are proficient in producing data in SEND (standard for exchange of nonclinical data) format. SEND is now mandatory for regulatory submissions to the US FDA.
Choose Eurofins CDMO to help you:
? Perform complete exploratory and regulatory IND-enabling toxicology studies
? NDA-enabling studies like repeated toxicology studies ranging from 3 months to 1 year duration, reproduction toxicology studies and carcinogenicity studies
? Impurity qualification toxicology studies
? Intravenous infusion toxicology studies
? Juvenile toxicity studies
Genotoxicity Studies
- Ames test
- In vitro mammalian chromosomal aberration test in human peripheral blood lymphocytes (HPBL) and CHO cells
- In vitro mammalian cell gene mutation test in mouse lymphoma cells using the Tk gene and in CHO cells using the Hprt gene
- In vitro micronucleus test in human peripheral blood lymphocytes (HPBL) and CHO cells
- In vivo micronucleus test in rat and mouse
Safety Pharmacology (In Vivo)
- In vitro hERG assay (CHO/HEK)
- Pulmonary function in rats
- Modified Irwin test (FOB) in rats
- Cardiovascular telemetry in dogs
- Gastrointestinal motility in rats
Toxicology Studies (In vivo)
- Maximum Tolerated Dose (MTD) toxicology studies
- Dose range finding toxicology studies
- 28-day Repeat dose toxicity studies with toxicokinetics
- Repeat dose studies ranging from 90 days to 270 days with toxicokinetics
- Developmental and Reproductive Toxicology Studies –
- Segment I – fertility studies
- Segment II – embryo-fetal studies
- Segment III – perinatal and postnatal studies
- Juvenile toxicity studies
- Carcinogenicity studies up to 24-months duration in rat and mouse, including 6-month carcinogenicity study in transgenic mouse (rasH2)
