Safety Pharmacology Studies

Everything you need to know about your agent before moving to efficacy testing

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"CrownBio brings clarity to drug discovery around the world by helping biopharmaceutical companies solve some of today's most pressing problems in oncology, cardiovascular, and metabolic disease.

Leveraging our industry expertise, CrownBio's global resources help customers answer the most challenging questions about human biology. We begin with the end insight to help you achieve your goals"

Dr Jean-Pierre Wery
CEO, Crown Bioscience Inc.

Want to Evaluate Potential Side Effects of Your New Agent? Discover How We Can Help

CrownBio’s General Toxicology Platform includes Safety Pharmacology studies to assess the potential side effects of your new agents. Our Safety studies can be provided either as standalone assessments, or embedded within our overall toxicological profiling.

Our comprehensive Safety Pharmacology evaluations in rodents and NHPs include assessments of:

System

NHP

Rodent

Cardiovascular

BP, HR including continuous telemetry monitoring, ECG, cardiac function via noninvasive echocardiography

BP, HR including continuous telemetry monitoring, cardiac injury biomarker panel (MSD)

Hepatic

Echo evaluation of fatty liver (for long term study)

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Metabolic

Long-term continuous monitoring of blood or interstitial glucose via telemetry device

Long-term continuous monitoring of glucose via telemetry device, biomarker assessment (std. ELISA and MSD)

Renal/urinary

Renal function, blood chemistry, protein assays

Renal function, blood chemistry, kidney injury biomarker panel (MSD)

To provide high definition data and enhanced Safety Assessment, CrownBio can perform both cardiovascular (blood pressure) and metabolic (glucose level) assessments via continuous telemetry monitoring. Blood pressure monitoring via radio telemetry is available for our NHP and rodent models. BP measurements can be performed over several months if needed, and experimental readouts include mean arterial pressure (MAP), systolic and diastolic pressures, and HR.

Continuous glucose monitoring is available for both our rodent and NHP models using DSI technology, allowing continuous biochemical and physiological evaluation post-agent administration. In rodents, the technique is available for rat models, and is currently undergoing final validation in mice. The telemetry device can be used for approximately four week studies (limited only by the probe lifetime which is based on the amount of glucose oxidase which can be loaded).

In NHP models we use the DSI HD-XG transmitter device for continuous glucose monitoring with a small repeater for remote signal collection. Blood glucose can then be monitored wirelessly and recorded continuously for more than 6 weeks, to provide high quality continuous data.

CrownBio provides a wealth of experience in Non-GLP Toxicology and Safety Pharmacology studies, contact us today for expert opinion and advice on your project needs.