Comprehensive Toxicology Studies for Radiopharmaceuticals
At Rdcthera, we excel in delivering comprehensive CRO services tailored for the radiopharmaceutical industry. Our proficiency in Toxicology Studies guarantees that new radiopharmaceuticals undergo rigorous safety evaluations. This meticulous approach empowers our clients to confidently and precisely navigate the regulatory landscape.
Introduction to Radiopharmaceutical Toxicology Studies
The safety of any new radiopharmaceutical must be assessed prior to clinical phase I studies to estimate the risk-benefit profile of the new drug. Typically, diagnostic radiopharmaceuticals are administered at tracer levels (μg/kg body weight), so much so that they do not cause biological effects. Consequently, no toxic effects are usually produced at that dose. However, some toxins are known to be lethal even at these dose levels and even lower. Therefore, it is important to study the toxicological effects of any new radiopharmaceutical.
Fig.1. Schematic design of radiopharmaceutical complex. (Del Olmo-García MI, et al., 2022)
Our Toxicology Study Services
Our range of toxicology services cover a wide array of preclinical studies, which are conducted to meet regulatory demands that support the development of safe and effective radiopharmaceuticals.
Single-Dosing Toxicity Studies
- Determine the acute effects of a radiopharmaceutical
- Monitor toxic potential of a single dosing administration
Repeated-Dose Toxicity Studies
- Understanding the chronic effects of continuous exposure to a radiopharmaceutical
- Understanding of the cumulative impact and delayed toxicities associated with the radiopharmaceutical
- Ensure robust safety profiles are established
Comprehensive Biochemical and Histopathological Analysis
Rdcthera offers comprehensive biochemical and histopathological analysis services. Such detailed analyses, derived from all lines of studies developed for the evaluation of radiopharmaceuticals, would provide a general view of the physiological and pathological effects that radiopharmaceuticals could cause.
- Clinical Chemistry
- Hematology
- Necropsy Data
- Histopathology
Pharmacokinetics and Dose Determination
A complete understanding of the pharmacokinetics (PK) of a radiopharmaceutical is crucial to optimizing the dosing regiment. We offer extensive PK services to investigate the rate of absorption, distribution, metabolism, as well as the excretion of radiopharmaceuticals.
Human Equivalent Dose (HED) Calculation
Translating data from animal studies to human applications accurately is difficult and necessary. Our HED calculation process entails complex modeling to ensure that the dose levels established for human studies are safe and effective and contain as little risk of side effects as possible.
Tailored Toxicology Services to Meet Your Needs
At Rdcthera, we recognize that each radiopharmaceutical is distinctive. Our tailored services offer individualized design and customized study parameters, ensuring each study is tailored to the requirements of your project. From concept to final analysis, we offer comprehensive services to move your radiopharmaceutical smoothly through the development pathway.
Partner with Rdcthera for expert toxicology studies driving the development of safe and effective radiopharmaceuticals. Contact us today for additional details on our capacities and ways to collaborate to meet your research and development needs.
Reference
- Del Olmo-García MI, Prado-Wohlwend S, Bello P, et al. (2022). Peptide Receptor Radionuclide Therapy with [177Lu]Lu-DOTA-TATE in Patients with Advanced GEP NENS: Present and Future Directions. Cancers (Basel). 14(3):584.
For research use only. Not intended for any clinical use.
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