Safety Pharmacology Services

Fully Compliant with US FDA, OECD, Chinese SFDA GLP Requirements

At WuXi AppTec our preclinical expertise extends into GLP-compliant safety pharmacology studies based on the requirements of the ICH S7A and S7B guidelines. Our integrated service platform includes extensive capabilities to assess effects on CNS, respiratory, cardiovascular, GI and renal systems, using both in vitro and in vivo studies, in line with our goal to help our worldwide customers shorten the time and lower the cost of R&D through cost-effective and efficient outsourcing solutions.

For Core Battery studies, CNS assessments are performed in rodents or non-rodents as required, using a Functional Observational Battery or Modified Irwin Screen. Respiratory parameters are routinely assessed in rodents via "head out" plethysmography, or in large animals using a pneumotach to measure respiratory rate, tidal volume and minute volume. For cardiovascular assessment, DSI telemetry systems are used to collect hemodynamic and ECG data, with in-house colonies of dogs and monkeys available for fast start-up of studies. Both respiratory and cardiovascular studies use the latest DSI Ponemah software to collect and analyze data in real time

WuXi AppTec's Safety Pharmacology program in Suzhou brings together an experienced team of industry scientists to design and optimize a panel of both GLP and non-GLP safety assessment assays.

Safety Pharmacology Services Include:

Safety Pharmacology ICH S7A Standard Battery

  • CNS (rodent and non-rodent)
  • Respiration (rodent and non-rodent)
  • Cardiovascular telemetry
  • Non-invasive DSI JET system assessments can be added to toxicology studies
  • hERG assay via manual patch clamp

Non-GLP Cardiovascular Safety Screening Assays

  • Rat telemetry (SHR, normotensive)
  • Anesthetized guinea pig QT assay
  • ECG and indirect BP in large animal
  • hERG via automated patch clamp