Aided by vast expertise and advanced in vitro disease models, Creative Biolabs provides the lead optimization services through a strategy and consultation-based approach with careful considerations. To support in vitro safety pharmacology studies, we established a comprehensive set of in vitro safety pharmacology core battery studies. Our multidisciplinary team will offer flexible solutions for your candidates.
Safety pharmacology is an essential component in drug development process which is to predict adverse effects prior to clinical trial stage. It’s crucial to understand and mitigate the potential adverse events caused by your drug candidates for a successful IND submission. In vitro safety pharmacology studies can provide insights into potential safety risks earlier in drug development.
Fig.1 Safety pharmacology core battery studies. (Pugsley, 2008)
As per International Conference on Harmonisation (ICH) guidelines - S7A and S7B, Creative Biolabs provides comprehensive and global in vitro safety pharmacology core battery studies to advance your program successfully. To facilitate the drug lead optimization, our scientists are innovating and accelerating 3D model-based assays and platforms covering major physiological organ systems in three areas - central nervous system, cardiovascular system and respiratory system. We are dedicated to providing integrated in vitro expertise for de-risking your candidates and helping you make smarter decisions in early preclinical development.
Creative Biolabs offers comprehensive in vitro models in various neurological areas - psychopharmacology, sleep-wake, epilepsy, and neurodegenerative disorders. We provide a full range of in vitro CNS safety pharmacology assessments including but not limited to: functional observation battery (FOB), modified Irwin screen, etc.
We have an extensive portfolio of cardiovascular in vitro safety pharmacology services including standard cardiovascular telemetry studies, and pathophysiological models. Our full spectrum of in vitro models enables us to perform comprehensive assessment of many cardiovascular readouts including blood pressure, heart rate, electrocardiograms (ECGs), ventricular pressure and pulmonary, and echocardiography, etc.
The in vitro respiratory safety pharmacology assessments can also be evaluated in Creative Biolabs. We have a variety of models to facilitate the respiratory-related readouts testing including respiratory rate, hemoglobin oxygen saturation, tidal and minute volumes.
Creative Biolabs provides our clients with the opportunity to investigate a wide range of safety pharmacological effects at considerably lower costs. Our scientists are committed to helping our clients rethink the ICH core battery and explore novel strategies for risk management during drug discovery and development. Reliable and user-friendly data will be delivered in cost-effective packages. Please don’t hesitate to contact us for further communications and a detailed quote.
Reference
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