Mitochondrial diseases encompass a diverse range of genetic disorders characterized by impaired cellular energy production, resulting in various clinical manifestations. Given the intricate nature of mitochondrial dysfunction and the potential impact of therapeutic interventions, rigorous safety pharmacology assessments are indispensable in drug development for these conditions. Protheragen offers a comprehensive Safety Pharmacology Service specifically tailored to meet the unique requirements of drug developers targeting mitochondrial dysfunction.
Our Services
Protheragen coordinates and curates tailored safety pharmacology studies across a diverse range of animal models for mitochondrial disease, facilitating a comprehensive approach to mitigate risks associated with compounds impacting multiple organ systems. This enables informed decision-making during early preclinical development.
Cardiovascular System Safety Pharmacology Service
Blood pressure, heart rate, electrocardiograms (ECGs), ventricular and pulmonary pressure, and echocardiography.
Respiratory System Safety Pharmacology Service
Respiratory rate, hemoglobin oxygen saturation, and tidal and minute volumes, in vitro electrophysiology.
Central Nervous System (CNS) Safety Pharmacology Service
Functional observation battery (FOB), modified Irwin screen, body temperature, and large animal neurological evaluations, quantitative motor performance, CNS electrophysiology (EEG), and higher order neurofunctional endpoints.
In Vitro Electrophysiology Safety Pharmacology Service
Complete cardiac ion channel assessments (e.g., Na+, Ca2+, K+ or hERG), the comprehensive in vitro proarrhythmia assay (CiPA) battery includes assessment of drug effects on multiple human cardiac currents using appropriate voltage protocols, in silico reconstruction of the human cardiac action potential, and evaluation of in vitro effects in human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs).
Renal/Urinary Safety Pharmacology Service
Serum creatinine, blood urea nitrogen (BUN), glomerular filtration rate (GFR), inulin or creatinine clearance, kidney injury molecule-1 (KIM-1), neutrophil gelatinase-associated lipocalin (NGAL), and urinary albumin.
Gastrointestinal Safety Pharmacology Service
Gastric emptying, intestinal transit time, colonic motility, gastrointestinal adverse effects, gastric mucosal integrity and barrier function.
Our Advantages
- Expertise
Our team comprises seasoned scientists with specialized knowledge in mitochondrial biology, pharmacology, and drug development. We harness this expertise to design and execute comprehensive safety pharmacology studies tailored to the unique requirements of mitochondrial disease research.
- Customized Solutions
We recognize that each drug development program is distinct, and we provide tailor-made solutions to address specific challenges and objectives related to mitochondrial disease. Whether it involves designing specialized assays or developing risk mitigation strategies for mitochondrial dysfunction, we collaborate closely with clients to achieve their goals.
- Efficiency
Efficiency is a key priority in our drug development process for mitochondrial disease treatments. We leverage state-of-the-art technologies and methodologies to deliver timely and reliable results. Our streamlined approach helps expedite the pace of drug development while upholding stringent safety standards.
- Collaborative Partnership
We consider our clients as partners and foster close collaboration throughout the entire drug development journey for mitochondrial disease therapies. From study design to data interpretation, we emphasize open communication and collaboration to ensure mutual success.
By leveraging our expertise, specialized assays, and collaborative approach, we assist our clients in navigating the intricacies of drug development while prioritizing safety and efficacy. Feel free to contact us today for further information on how we can support your drug development efforts in the field of mitochondrial diseases.
