Why Conduct Safety Pharmacology Studies

Safety pharmacology meets significant requirements in drug development. It is an assessment of any potential adverse pharmacological effects for candidate drugs on the major physiological systems of the human body. Based on safety pharmacology studies, strategies can be developed to advance your drug candidate.

Services Overview

Safety pharmacology studies are a crucial step in evaluating acute and potentially life-threatening risks of novel drugs. Ace Therapeutics' talented scientists help mitigate risk by evaluating programs at the discovery/leader optimization stage. As a global CRO in ophthalmology research, we provide comprehensive and systematic in vitro safety and pharmacology research for the development of global customers ophthalmic products.

Ace Therapeutics provide thousands of in vitro assays, including cell-based assays and 3D model-based assays, to assess a wide range of safety-relevant endpoints. Our research can be used throughout your drug development process to reduce risk. Our scientific expertise and accurate data will provide valuable insights to aid decision-making in your drug discovery program. We specialize in performing standard and custom in vitro pharmacology studies cost-effectively with reproducible high-quality data and fast turnaround times.

Explore Our Capabilities

For ophthalmic small molecule targeted drugs in development, a series of core safety pharmacology studies must be conducted in accordance with regulatory guidelines (ICH S7A/S7B) before the first human administration. We provide the following in vitro safety pharmacology research services, including but not limited to.

• In Vitro Model

To facilitate our in vitro safety and pharmacology studies, we have established a series of in vitro models, including 2D cell models and 3D models. For 2D cell models, we offer primary cells, patient-derived cells, cell lines and stem cells, which are common tools for developing different types of in vitro models. For 3D models, we have dedicated 3D culture platforms to support spheroid and organoid models.

• Complementary Safety and Pharmacology Studies

Ace Therapeutics provides secondary studies of supplemental safety pharmacology to assess potential adverse effects on other organ systems. These include renal/urinary, autonomic nervous system and gastrointestinal system. For urogenital function, we provide diuresis and excretion of urinary electrolytes, bladder activity and key urinary parameters. For gastrointestinal function, we performed intestinal and colonic transit, gastric acid secretion, and gastric emptying studies.

• Special Toxicity Studies

Ace Therapeutics' Scientists are still innovating assays and tools for specialized toxicity studies, including genotoxicity studies, carcinogenicity studies, reproductive toxicity studies, and drug dependence. Our integrated in vitro expertise and toxicity studies provide you with a comprehensive approach to making effective decisions in the early development of your drug candidates.

Benefit from our state-of-the-art facilities, extensive expertise and decades of experience in lead optimization. Excellent track record of our experts when it comes to ophthalmic molecule lead optimization. Ace Therapeutics has created a series of in vitro models to provide in vitro safety pharmacology studies that meet stringent requirements and help you make critical decisions. We are committed to optimizing your lead candidate and delivering accurate data for IND application. If you want to know more about in vitro safety and pharmacology rtudies or have any special needs, please do not hesitate to contact us.

• In Vitro ADME Services
• Early Ocular Toxicology Services
• Ocular Pharmacokinetic (PK) Services
• Ocular Pharmacology and Pharmacodynamics Services

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