Toxicokinetics (TK)
Toxicology, safety pharmacology and preclinical drug safety
Toxicokinetics (TK) is a compound term derived from toxicology and kinetics, often referred to as "toxicant kinetics" or "toxicity kinetics." This field combines principles from pharmacokinetics to explore the occurrence and development of drug toxicity. It quantitatively studies the absorption, distribution, metabolism, and excretion (ADME) of drugs at toxic doses, providing a scientific basis for toxicity and safety evaluation.
What Specialty Values Prisys Could Offer in drug safety assessment in NHP?
Extensive Experience & Regulatory Expertise:
- Prisys boasts a proven track record in conducting diverse safety studies and generating high-quality data suitable for IND submissions, ensuring regulatory compliance and successful drug development.
Clinically Translatable Safety Insights:
- Leveraging advanced technologies like in vivo imaging and a specialized team of NHP veterinarians and a human physician, Prisys provides clinically relevant safety assessments and expert diagnosis, bridging the gap between preclinical and clinical research.
Neurotoxicity Evaluation:
- Prisys utilizes proprietary BehaviorAtlas™ 3D motion quantification and telemetry implants for advanced neurotoxicity assessments, enabling precise and objective evaluation of drug effects on the nervous system.
Specialized Technical Prowess:
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Our team possesses expertise in complex procedures, including handling complicated terminal sampling (e.g., deep brain nuclei ), ensuring accurate and reliable data collection from various target organs.
Robust & Integrated NHP Models:
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Prisys utilizes well-characterized NHP models in safety pharmacology studies, covering key areas like hematology, metabolism, respiratory function, and CNS effects, providing comprehensive insights into drug safety profiles.
Comprehensive Toxicokinetic (TK) Capabilities:
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Prisys offers integrated TK studies, diverse drug delivery options, advanced sample harvesting & processing techniques, and a wide array of analytical experiments, ensuring robust and detailed TK analysis crucial for drug safety evaluation.
For further information on our TK services or to discuss your specific requirements, please contact us for expert support.
FAQ
Q: What is Toxicokinetics (TK)?
Q: Key Objectives and Tasks of TK Studies
- Systemic Exposure Description: Quantitatively describe systemic exposure in animals and its relationship with toxic doses and timeframes.
- Dose and Absorption Relationships: Understand the relationship between high doses and absorption rates, including gender differences.
- Repeated Dosing Effects: Clarify the impact of repeated dosing on drug metabolism and kinetics.
- Drug Accumulation and Target Organs: Determine the sites and extent of drug accumulation, predict target organs for toxicity, and elucidate the mechanisms of toxic action through exposure and time-dependent studies.
- Toxic Response Identification: Identify whether toxicity is caused by the parent drug or its metabolites and clarify species differences in toxic responses.
- Support for Toxicology Study Design: Align TK dosing regimens with those in toxicology studies to enhance the design of animal toxicology studies, including species and dose selection.
- Extrapolation to Humans: Compare animal and human systemic exposures to interpret toxicology data, establish the relationship between toxicology study doses and clinical doses, and ensure clinical safety.
- Guidance for New Drug Design: Provide guidance in designing new drugs to avoid toxic moieties in parent drugs or metabolites.
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