Preclinical Safety
Pharmacology Services

Safety pharmacology is a critical step for drug approval and successful entry into the global marketplace. These studies demand significant time, investment, and specialized expertise. Delays caused by inefficient processes, inaccurate data, or unforeseen challenges during preclinical development can result in lost business opportunities. Careful selection of models and strict adherence to regulatory requirements are essential for in-vivo studies that leverage true safety pharmacology expertise.

Safety Pharmacology Study Capabilities

With over 30 years of experience, AmplifyBio excels in preclinical research, toxicological solutions, modern pharmacokinetics, and extensive safety pharmacology studies. We collaborate closely with clients, designing tailored studies for human and animal models, supported by physiological expertise to interpret and implement data in real time. Our skilled team ensures flexible, compliant testing aligned with ICH standards, delivering reliable results to advance your drug development process.

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:

Preclinical Toxicology Studies and Services

Radiotelemetry of physiological data, both implanted and external (JET) devices

  • Electrocardiograms (ECGs) – Heart rate, rhythm, and arrhythmia analysis 
  • Blood pressures  
  • Ventricular pressure readings 
  • Respiratory rate and tidal volume 
  • Temperature and activity data 
  • Electroencephalograms (EEGs) 
  • Species: rat, dog, pig, non-human primates 

Plethysmography

  • Respiratory rate and tidal volume 
  • Inspiratory and Expiratory flows and durations 
  • Indices of pulmonary resistance 
  • Direct measurement of pulmonary resistance and compliance (when coupled with radiotelemetry for intrathoracic pressure data) 
  • Real-time pulmonary parameters collected with aerosol delivery of test article 
  • Species: rat, dog, pig, non-human primates 

Anesthetized Models

  • Pressure volume loops
  • Hemodynamic parameters 
  • Ultrasound evaluations 
  • Cardiac catheterizations using fluoroscopy 
  • Species: mouse, rat, dog, pig, non-human primates 

Expertise in Safety Pharmacology

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.

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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

Additional Preclinical CRO and CDMO Services

Contact Us

AmplifyBio is your trusted partner for in-vivo safety pharmacology solutions. With expertise in designing the right studies for every model and the flexibility for data-driven implementation, we ensure your preclinical studies meet safety and compliance requirements. Connect with us to discover how our safety pharmacology expertise can support your research.