As a global CRO with ample laboratory capacity and extensive regulatory expertise, Creative Biolabs ensues our clients that fully compliant results will be delivered in the agreed timeline promised. We can accommodate the specific requirements and properties of your candidate, and propose the most appropriate in vitro safety pharmacology studies to help you make smarter decisions.
Safety pharmacology satisfies a vital requirement in the drug development process. It is to assess any potential undesirable safety pharmacological effects on the body’s major physiological systems caused by drug candidates in relation to exposure in the therapeutic range and above. Based on the results of safety pharmacology studies, corresponding strategies can be developed to advance your drug candidates.
As a leader in providing in vitro safety pharmacology studies, we have thousands of in vitro assays including cell-based assays and 3D model-based assays to evaluate a wide range of safety-related endpoints. Our studies can be used throughout your drug development process to help de-risk your candidates. Our scientific expertise and accurate data will provide valuable insights which can facilitate your decision-making in your drug discovery program. We are focused on both standard and custom in vitro pharmacology studies in a cost-effective manner with reproducible, high-quality data, and fast turnaround timeline.
To facilitate our in vitro safety pharmacology studies, we established a series of in vitro models including 2D cell models and 3D models. For 2D cell models, we provide primary cell, patient derived cell, cell line and stem cell which is a popular tool to develop different kinds of in vitro models. For 3D models, we have specialized 3D culture platform to support spheroid and organoid models. With innovative technologies, our scientists also have developed organ-on-chip models, 3D bio-printed models and tissue engineered models to fit your stringent requirements.
For an investigational drug, a core battery of safety pharmacology studies must be conducted before first administration to humans in compliant with regulatory guidelines (ICH S7A/S7B). We provide a comprehensive set of assays to evaluate the candidates’ safety effects on cardiovascular, respiratory and central nervous systems.
We also provide second-tier studies for supplemental safety pharmacology to evaluate potential adverse effects on other organ systems including renal/urinary system, autonomic nervous system, and gastrointestinal system. For urogenital function, we provide diuresis and excretion of urinary electrolytes, bladder activity, and main urinary parameters. For gastrointestinal function, we have intestinal and colonic transit, gastric acid secretion, and gastric emptying studies.
Creative Biolabs scientists are still innovating the assays and tools for special toxicity studies including genotoxicity study, carcinogenicity study, reproductive toxicity study, and drug dependence. Our integrated in vitro expertise and toxicity studies provide a comprehensive approach for effective decision making in early development of your candidates.
Supported by our multidisciplinary team with flexible solutions, the specific properties of your project will be tailored and flexible customized solutions will be provided. Creative Biolabs pioneered a series of in vitro models for the delivery of in vitro safety pharmacology studies that fulfill the stringent requirements and help you make critical decisions. We are committed to optimizing your lead candidate and providing accurate data for IND application. Please feel free to contact us to learn how we can be involved in your lead optimization project.
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