Exploratory Studies
Exploratory studies are designed to support early-stage decision-making by providing rapid, focused safety and exposure data. These studies help identify potential liabilities, guide dose selection, and prioritise candidates before advancing into more resource-intensive regulatory toxicology programs.
Adgyl Lifesciences offer a range of exploratory in vivo studies in rodents and non-rodents, including single-dose studies in rodents with minimal parameters and short-duration repeat-dose toxicity studies of 4 or 7 days in rodents and non-rodents. These studies include limited histopathological evaluation and plasma exposure assessments, enabling early insights into tolerability, systemic exposure, and dose range optimisation.
Our exploratory portfolio also includes targeted safety pharmacology and genetic toxicology screens. These involve in vitro mini hERG assays, in vivo cardiovascular function assessment in telemetered dogs, and mini Ames testing for early genotoxicity risk evaluation. Together, these flexible and efficient studies support informed go/no-go decisions and de-risk progression into formal development programs.
Key services include:
- Mini Ames
- Mini hERG (hERG screening)
- Dose range finding studies
- Screening CVS function in telemetered dogs
Adgyl Lifesciences offers following IND enabling studies:
Exploratory studies (Non-GLP)
- Mini Ames
- Mini hERG (hERG screening)
- Dose range finding studies
- CVS function screening in telemetered dogs
Genotoxicity (GLP)
- Ames Test
-
In vitro Chromosomal aberration test in Human
Peripheral Blood Lymphocytes (MUT CHAB/HPBL) - Micronucleus test (MNT) in Mice/Rats
Process Hazard Analysis
- hERG assay
- Modified Irwin Test/Functional Observation Battery in rats (FOB-Rats)
- Pulmonary functions(Rats)
- CVS function assessment using telemetered dogs
Toxicology studies (GLP)
- Maximum Tolerated Dose (MTD) followed by 10 day repeat dose range finding(DRF) in Rat
- 28-Day Repeat dose toxicity study in Rat
- Maximum Tolerated Dose (MTD) followed by 10 day repeat dose range finding(DRF) in Dog
- 28 Day Repeat dose toxicity study Dog
Scientific Partnership
Partnering for Scientific Excellence
Adgyl Lifesciences is committed to ensure
Scientifically rigorous, reproducible and timely study execution.
High‑quality data generation aligned with scientific & regulatory requirements
Seamless end‑to‑end support spanning study design, execution, and data interpretation.
Connect with our expert team today to discuss how we can support your exploratory studies.
what people ask
Frequently Asked Questions
Can these studies replace full regulatory toxicology studies?
No. Exploratory studies provide preliminary insights for decision making, study design, dose selection, and risk mitigation before initiating formal toxicology programs. Exploratory studies are not intended to replace GLP regulatory studies.
What is the typical duration of exploratory in vivo studies?
Exploratory in vivo studies are of short duration, typically ranging from single‑dose to repeat‑dose studies lasting 4 to 7 days, enabling rapid data generation.
Are cardiovascular risks assessed at this early stage?
Yes. Early cardiovascular risk assessment is supported through in vitro mini hERG screening and in vivo telemetry‑based cardiovascular studies in dogs, helping identify potential liabilities early.
Is pathology involved and if yes, to what extent?
Pathology assessments are intentionally limited and focused, providing sufficient information to identify major findings while maintaining fast timelines and cost efficiency.
How customisable are your exploratory study designs?
Exploratory studies are highly flexible and can be customised based on compound properties, target indication, and specific development questions.
