Dose Range Finding (DRF)
Dose-Range-Finding (DRF) toxicity studies are a critical component of the preclinical development phase in drug research. These studies aim to determine the appropriate dose levels for subsequent safety studies by evaluating the tolerability and toxic effects of a compound across a range of doses. The ultimate goal is to identify the maximum tolerated dose (MTD) and establish a dosing regimen that is both effective and safe for further testing.
In the context of non-human primates (NHPs), particularly Cynomolgus monkeys, DRF studies are invaluable due to their close physiological similarities to humans, which provide more predictive insights into the potential human response to a new therapeutic compound.
Conducting DRF Toxicity Studies in Cynomolgus Monkeys
At Prisys Biotech, we conduct rigorous DRF toxicity studies following established guidelines such as the ICH S9 (Advanced Oncology) and ICH S3A (Toxicokinetics) to ensure compliance and reliability of results. Our studies typically span 2 to 4 weeks, during which the test compound is administered to Cynomolgus monkeys via the method that ensures precise dosing.
Study Design and Methodology
The study design involves a dosing regimen that follows a 3-days-on/4-days-off schedule, allowing us to observe the effects of the compound during both the dosing and recovery phases. The experimental groups consist of male and female Cynomolgus monkeys, divided into low, mid, and high-dose groups, receiving the test compound for pharmacokinetic study.
Key assessments include:
- Clinical Observations: Conducted daily, with detailed observations prior to dosing and at scheduled intervals to monitor the animals' well-being.
- Body Weight Monitoring: A crucial indicator of overall health, tracked weekly and on the day of scheduled necropsy.
- Toxicokinetic Sample Collection and Analysis: Blood samples are collected at multiple time points post-dosing, analyzed using advanced LC-MS/MS techniques to determine key pharmacokinetic parameters such as Cmax, Tmax, and AUC.
Termination and Pathology Procedures:
Upon study completion, all animals undergo a thorough necropsy to identify any macroscopic lesions. Selected organs are weighed, and tissues are collected for histological examination. For animals that succumb or require early euthanasia, a full necropsy is performed to ascertain the cause of death, with tissues processed and analyzed similarly to those from scheduled terminations.
Advantages of Conducting DRF Studies at Prisys Biotech
Expertise in NHP Models :
With a strong focus on Cynomolgus monkeys, our team possesses extensive experience and knowledge in handling and studying this species, ensuring high-quality data and reliable results.
Comprehensive Toxicology Assessments:
Our studies encompass a wide range of toxicology assessments, from clinical pathology to advanced ophthalmic examinations, providing a holistic view of the compound's safety profile.
Cutting-Edge Analytical Capabilities :
Utilizing state-of-the-art technology such as LC-MS/MS for toxicokinetic analysis, we deliver precise and accurate data that supports critical decision-making in drug development.
Regulatory Compliance:
Our adherence to FDA/OECD non-GLP standards and ICH guidelines ensures that our studies meet the necessary regulatory requirements, facilitating the progression of compounds through the drug development pipeline.
At Prisys Biotech, we are committed to advancing preclinical research through meticulous and scientifically rigorous DRF toxicity studies in Cynomolgus monkeys. Our expertise, state-of-the-art facilities, and adherence to global standards position us as a trusted partner in the journey of drug discovery and development.
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