In vivo Non-GLP Exploratory Toxicology

In vivo Non-GLP Exploratory Toxicology

At Acubiosys, our experienced team can make a difference to the clients by designing time and cost-effective strategies for early toxicology assessment of a compound or compound series. These strategies mitigate risks earlier and before a compound enters pre-clinical development. Importantly the information obtained can be rapidly used to engineer out toxicological liabilities and accelerate the route to the clinic.

Early, exploratory safety assessment usually includes pharmacology studies, general toxicity studies, toxicokinetic and nonclinical pharmacokinetic studies, reproduction toxicity studies, cardiotoxicity and genotoxicity studies and, for drugs that have particular cause for concern or are intended for a long duration of use, an assessment of carcinogenic potential.

  • Exposure, toxicokinetics and tolerability studies including safety pharmacology/safety margin (MTD, NOAEL).
  • Maximum Tolerated Dose (MTD)
  • 7-day or 28-day tox (non-GLP)
  • Dose range finding studies. Dose-escalation studies or short-duration dose-ranging studies define an MTD in the general toxicity test species.
  • Formulation assessment.
  • Tissue analysis.

In vitro metabolic and plasma protein binding data for animals and humans and systemic exposure data in the species used for repeated-dose toxicity studies should be evaluated.

Drug-drug interactions (DDI) refer to simultaneously administered drugs that interfere with each other’s absorption, distribution, metabolism, and elimination (ADME).

  • CYP450 induction and inhibition.
  • UGT induction and inhibition.
  • Time-dependent inhibition.
  • Transporters (OATPs, OATs, OCTs, MATE).
  • Target engagement.
  • Safety and efficacy biomarkers.

Our streamlined procedures and targeted reports allow us to offer credible data with operationally efficient services. Working with Acubiosys will enable you to incorporate the industry’s best practices into your drug testing program.