ICH testing 

Assessing potential safety liability early

Essential to optimizing drug design and progression into non-clinical development is assessment of safety with understanding of therapeutic related aspects such as DMPK. This requires timely and integrated approaches to understand and, as needed, address potential inherent target or compound related issues.

Creating a solid foundation to enable further development

In early discovery, where decisions need to be made quickly to enable rapid progress, often on limited budgets, quality data that can be relied on is key to create the foundation for success. Working with a partner that can help you by doing the right study to answer the right question is key.  

Innovative modalities need innovative approaches

Whether your therapeutic is a based on an established large or small molecule platform, is a complex medicine, or an advanced therapy technology; assessing relevant potential safety vulnerability is essential to translation of brilliant science into an impactful therapy. Our scientists, our models and our depth of experience provide clients at the cutting edge, with the right resource to support them.

End-to-end compliance with ICH S7 Guidelines

These studies are designed to identify the undesirable pharmacodynamic properties of a compound relevant to human safety in three areas — Cardiovascular, Respiratory and the Central Nervous System. 

New ICH E14/S7B Q&A Guideline: Remove clinical TQT burden with high-quality double-negative preclinical data

With the release of the new ICH E14/S7B Q&As, for the first time, preclinical in vitro and ECG data can now be used to impact clinical ECG study design. Compounds that are deemed a low risk based on preclinical data (hERG and in vivo QT) allow sponsors more options to substitute the human Thorough QT (TQT) trial with ECGs collected in Phase I, reducing the overall industry TQT burden for low-risk compounds. We have in place the new quality standards for both hERG and the ECG telemetry studies that demonstrate achievement of sensitivity to detect QT changes equivalent to what can be achieved through testing in the clinic. Moreover, we have been at the forefront of numerous Q&A industry groups and presentations and are publication coauthors on the Q&As. Let us educate you on how  to best apply the new guidance to your drug development portfolio.

We partner with you on the following studies

• Cardiovascular system
  • Chronically instrumented conscious canine, NHP and minipig telemetry models
• Respiratory system
  • Rodent whole body and head-out plethysmography
  • Arterial blood gas in nonhuman primates
• Central nervous system
  • Modified Irwin test in rodents and nonhuman primates
  • Automated behavioral assessment in nonhuman primates
• Combination cardiovascular/respiratory
  • Jacketed assessments with respiratory inductive plethysmography