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Safety Pharmacology

WIL Research Laboratories, LLC provides comprehensive safety pharmacology testing services designed to provide the necessary information for worldwide registration of novel drugs and for filing Investigational New Drug (IND) Application prior to Phase I studies.

The ICH guidelines on safety pharmacology (ICH S7A and S7B) provide recommendations for evaluating the potential for adverse effect on major organ systems of the body and also for assessment of QT prolongation. The core battery of tests indicated by the S7A guidelines involves assessments of effects on the central nervous system (CNS), cardiovascular and respiratory systems. In addition, the S7B guideline recommends a strategy for a comprehensive assessment of the potential for QT prolongation using in vivo and in vitro assays.

In addition to the core testing batteries, the guidelines recommend a second tier of testing to either further evaluate and develop a greater understanding of mechanistic effects on vital functions or to evaluate potential adverse effects on other organ systems (e.g., renal/urinary system, gastrointestinal system).

WIL has the safety pharmacology expertise and equipment to perform complete safety assessments.

Capabilities

Core Battery

• Central Nervous System:
  Functional observation battery to detect effects on behavior, coordination sensory/motor reflex and locomotor activity
• Cardiovascular System:
  Blood pressure, heart rate, ECG and body temperature in conscious telemetered animals
• Respiratory System:
  Respiratory rate, tidal volume and minute volume; blood gas measurement
• In vitro Electrophysiology:
  (Offered through collaborative agreement with ChanTest, Inc.) Cloned human potassium channels (hERG)

Second Tier

• Renal/Urinary system: Renal function and general clinical chemistry
• Gastrointestinal: motility and function
• Pro -/anticonvulsant screening
• Enzyme completion/CNS depression
• Neuromuscular function
• Sensorimotor reactivity (startle habituation)
• Neuromotor coordination
• Learning and memory
• Drug dependency
• Nociception assessment
• Cardiac action potential
• ECG and MAOPD in the isolate heart

Experienced with all standard rodent and non-rodent laboratory animals including NHP.