AmplifyBio company

Safety Pharmacology

The choice of models and adherence to regulatory requirements must be carefully strategized for in-vivo studies that leverage safety pharmacology expertise. AmplifyBio utilizes over 30 years of experience leading preclinical research, creating toxicological solutions, developing modern pharmacokinetics, and assisting with many other extensive safety pharmacology studies. We work with our partners, providing experienced study designs for chosen models (human and animal trials) with physiological expertise to interpret and implement data in real-time. Our skilled team can adjust as needed and will conduct testing that meets regulatory requirements, including ICH safety pharmacology S7A and S7 standards.

Assessment Capabilities

AmplifyBio coordinates and curates customized safety pharmacology studies in a wide variety of animal models. The most common testing applications are cardiovascular, central nervous system (CNS), pulmonary, and renal therapies.

Our assessment capabilities include:

  • Telemetry implanted and external (JET) devices
  • Electrocardiograms (ECGs)
  • Heart rate, rhythm, blood pressure, ventricular and blood pressure readings
  • Respiratory rate, flow, saturation, and tidal volume
  • Behavior, motor activity, reflex response, and performance monitoring
  • Functional Observational Battery (FOB)
  • Electroencephalograms (EEGs)
  • Temperature and activity data
  • A wide variety of dose ranges and routes
  • Traditional therapeutics for small molecules
  • Advanced therapies for large molecules/biologics

The AmplifyBio Difference

At AmplifyBio, we use more than safety pharmacology expertise and best practices to assist with testing. We know that picking the best animal model, designing the right study, and being prepared to analyze all data with pharmacology and physiological expertise positions us to expect the unexpected and adjust at a moment’s notice.

vet surgeons

Our global partnerships, including our research collaboration with Battelle, enable new levels of innovation:

  • Accurate, reliable results for every study
  • Industry-leading safety pharmacology research and study group
  • World-class in-house surgical suites with full veterinary staff and surgical support
  • ICH, FDA, EPA, GLP, and many other compliance requirements met
  • Support for numerous animal types and dose routes
 

Other Services

  • In-House Surgical
  • General Toxicology
  • Inhalation Toxicology
  • Pathology
  • Analytics

Contact Us

With the expertise to design the right study for every model and flexibility for data-driven implementation, Amplifybio is your partner to trust for in-vivo safety pharmacology assistance. Talk with us and discover how we can support your study and compliance requirements.