Pharmacology and Safety-Toxicology

DECRO offers a sophisticated approach for evaluating the pharmacological effects of novel compounds on disease models. Its non-invasive nature provides a distinct advantage by preventing additional stress on models already compromised by their condition, thus ensuring more accurate and representative data.

Example: non-invasive ECG assessment can be readily employed in rat Chronic Kidney Disease (CKD) models to evaluate the efficacy of mineralocorticoid receptor antagonists. This lightweight approach allows for continuous, high-fidelity monitoring of cardiac function without imposing further burden on the animals, providing precise insights into treatment response.

Assessing acute and potentially life-threatening risks of novel pharmaceuticals is a critical step in IND-enabling studies with a primary focus set on the cardiovascular, respiratory, and central nervous systems, in line with ICH S7 and S6 guidelines for safety assessment. In this contexte, DECRO offers robust capabilities for safety assessment in both rodent and non-rodent species (dogs, minipigs, and marmosets) with comprehensive respiratory core battery assessment and Electrophysiological evaluation in unrestrained animals, including extended-duration QT prolongation assessment (ICH E14/S7B). Moreover, non-invasive jacketed telemetry systems ease the implementation of standalone safety pharmacology studies or, more beneficially, smoothly integrate into combined designs as recommended by ICH M3(R2). As a result, this allows CROs to propose enhanced ICH S7 core battery safety pharmacology studies to their sponsors.

In rodents, DECRO facilitates the integration of ICH S7 Core Battery CNS and respiratory endpoints into a single study design, thereby significantly improving development time and resource utilization (link to ERBC paper).

Similarly, in non-rodent studies, jacketed telemetry enables efficient repeated evaluation of safety endpoints within repeated-dosing toxicology studies (e.g., 4 or 13 weeks). This integrated approach efficiently provides robust safety data without increasing the overall animal burden required for the IND submission package.