• search
Country
CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Safety Pharmacology Services

Safety Pharmacology 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.

Speak to our experts

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 escape Piloerection
Reactivity to handling Exophthalmos
Fur appearance Pupil size
Salivation Body/muscle tone

Observations in standard arena:

Arousal Hypoactivity
Hyperactivity Grooming
Palpebral closure Tremors
Twitches Clonic convulsions
Tonic convulsions Ataxia
Hypotonia Gait
Posture Stereotypy
Abnormal behavior Breathing
Defecation and Urination Rearing

Manipulative tests:

Somatosensory/ touch response Tail pinch response
Visual approach response Palpebral reflex
Pupillary light reflex Righting 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

Virtual Tour

 

Contact Us

Country
CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
resourceMainImage

JUNE 28, 2022

Neoantigen Specific T cells For Cancer Immunotherapy

Neoantigen specific T cells for cellular cancer immunotherapy An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence...

Read More
resourceMainImage

Building successful long-term partnerships with CDMOs from early drug discovery through commercialization

Building successful long-term partnerships with CDMOs from early drug discovery through commercialization Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contr...

Read More
resourceMainImage

Technology meets sustainability - How a complex API development process goes green

We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...

Read More

Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug

2023

Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...

Read More
View All
×

You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.

If you wish to continue to this external website, click Proceed.

ProceedBack