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Safety Pharmacology Studies and Services Safety Pharmacology Studies and Services

Safety Pharmacology Studies and Services

We offer a variety of safety pharmacology services such as the hERG assay to screen compounds for cardiotoxicity and rodent FOB studies (modified Irwin test) for neurobehavioral effects.

The cardiac potassium channel, hERG is responsible for a rapid delayed rectifier current (IKr), which is primarily responsible for cardiac Action Potential (AP) repolarization. The unique structural properties of hERG make it vulnerable to interaction and inhibition by large numbers of compounds. Inhibition of IKr is the most common cause of cardiac AP prolongation by non-cardiac drugs. Prolonged AP causes prolongation of QT interval and has been associated with fatal ventricular arrhythmia, and Torsade de Pointes - which has led to a number of drug withdrawals and failures.  

We conduct a Functional Observational Battery (FOB) test for the assessment of neurobehavioral changes induced by the test compound. Typically, various graded concentrations of test articles are formulated in suitable vehicles and administered to rats or mice. Studies are conducted as a single exposure regimen or as part of repeat dose toxicity studies. The pre and post-dose FOB measurements on the same day are made to evaluate the intra and intergroup comparison of effects.  

Our scientists have vast experience in handling various test modules. The studies are conducted in full GLP compliance and data are reviewed by the Quality Assurance team.

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hERG Assay

In vitro assessment of new chemical entities (NCEs) for the effects on hERG potassium channels is an early indicator of possible QT prolonging effect. Patch clamp-electrophysiology is the gold standard for such an assessment. In addition to patch clamp assay, we also offer kit-based hERG assay for the preliminary screening of compounds.

Functional Observational Battery (FOB) study (Modified Irwin’s test)

Home cage observations:

  • Posture
  • Abnormal vocalization
  • Tremors
  • Convulsions

Handheld observations:

Touch escapePiloerection
Reactivity to handlingExophthalmos
Fur appearancePupil size
SalivationBody/muscle tone

Observations in standard arena:

Palpebral closureTremors
TwitchesClonic convulsions
Tonic convulsionsAtaxia
Abnormal behaviorBreathing
Defecation and UrinationRearing

Manipulative tests:

Somatosensory/ touch responseTail pinch response
Visual approach responsePalpebral reflex
Pupillary light reflexRighting reflex
Auditory startle reflex--

Motor activity:

Motor activity is measured using an automated motor activity measuring system (OptoM3 activity meter with CI Multi device interface, Columbus Instruments, USA). Animal activity will be measured for a period of 30 minutes for each animal.

Grip strength:

The grip strength meter measures the maximal muscle strength of the forelimb and hindlimb. For each animal, three readings will be recorded for forelimb and hindlimb using a Grip Strength Meter (Columbus Instruments, USA).

Landing foot splay:

Body temperature: Rectal temperature will be recorded at the end of FOB observations using a digital thermometer.

Why Aurigene Pharmaceutical Services?

Quick turnaround time

State-of-the-art facilities

Extensive experience in the hERG assay & GLP FOB studies

Team of expert scientists

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