In Vivo Safety Pharmacology Services for Radiopharmaceuticals
Rdcthera is a preclinical CRO specializing in providing comprehensive in vivo safety pharmacology research services for radiopharmaceuticals. Our expert team adheres to international regulatory guidelines, including those outlined in ICH, S7A, and S7B, to ensure that your data meets all regulatory standards and facilitates a smooth transition from preclinical trials to first-in-human studies.
Safety Pharmacology in Drug Development
Safety pharmacology is a critical step in the drug development process that seeks to uncover any potential deleterious effects of a drug on vital organ systems before the clinical trial stage. Such knowledge of these effects will contribute to mitigating risks early for safety and efficacy in radiopharmaceuticals in patients.
Fig.1. Schematic representation of the different strategies applied or under investigation to reduce the renal uptake of bio-vector radiopharmaceuticals. (Funeh CN, et al., 2023)
Our In Vivo Pharmacology Services
We take an integrated approach where the endpoints for safety pharmacology are placed within our toxicity studies on repeat dosing. Our services range across in vitro to in vivo, spanning a wide array of assessments in order to evaluate the cardiovascular, respiratory, and central nervous systems.
Solutions Tailored to Suit Your Needs
Although each radiopharmaceutical project differs in its own unique way, we still offer customized services designed for your requirements. Our professionals will guide you through planning and executing studies that will meet your development goals and expectations from the regulatory authorities.
Our Expertise in Safety Pharmacology
We can conduct a wide array of safety pharmacology studies on radiopharmaceuticals under development, focusing on the main potential risks. We use advanced animal models for testing to provide accurate and reliable data.
Cardiovascular System Assessments
We conduct detailed cardiovascular system evaluation using the latest techniques and models for heart rate, blood pressure, and electrocardiogram parameter monitoring. These assessments are very essential in identification of the cardiotoxic effects at an early stage of development.
Central Nervous System Evaluations
Our key activities in the central nervous system research fields are related to behavioral and neurophysiological parameters. To this end, we use specifically developed animal models to study the potential influence of radiopharmaceuticals on the functions of the CNS and ensure that possible adverse effects are detected and solved on time.
Respiratory System Analysis
We perform detailed respiratory function evaluations for parameters like respiratory rate, tidal volume, and gas exchange. These studies identify respiratory toxicity and allow for the preparation of a full safety data package for regulatory submissions.
Safety Pharmacology Applications
Early safety pharmacology evaluations in the drug development process make it possible to identify proactively risks and mitigation measures associated with them. This strategy aims to comply with the regulatory requirements of developing safer, yet more effective, radiopharmaceuticals.
For further information on our in vivo safety pharmacology services and how we can support your radiopharmaceutical development, contact us now. Our team is at your beck and call to offer you the support and expertise necessary to drive your projects forward with confidence.
Reference
- Funeh CN, Bridoux J, Ertveldt T, et al. (2023). Optimizing the Safety and Efficacy of Bio-Radiopharmaceuticals for Cancer Therapy. Pharmaceutics. 15(5):1378.
For research use only. Not intended for any clinical use.
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