IITRI - Safety Pharmacology Assess New Pharmaceuticals ICH S7A ICH S7B Guidelines Central Nervous System, Respiratory System, Cardiac System, Immunology System

Safety Pharmacology

Safety pharmacology studies identify a drug's adverse effects and preview what may be observed clinically. IITRI has the proven skills to assess new pharmaceuticals using safety pharmacology tests. We can also perform secondary testing to define possible mechanisms by which side effects occur.

This is a thrilling and challenging area of safety pharmacology, as each new pharmaceutical tested is generally unique both mechanistically and therapeutically, such that each project may require the development of creative testing solutions.

Areas of Expertise Include:

Central Nervous System
Home-cage observation	Catalepsy
Hand-held observation	Extensor thrust
Open-field (mobility/gait)	Righting reflex (aerial, ground)
Vision	Visual placing
Eye blink	Tactile placing
Pupil response	Negative geotaxis
Tail pinch	Grip strength
Hindlimb extension	Foot splay
Audition (click, startle)	Body temperature
Irvin behavior test

Respiratory System
Tidal Volume	Expiratory time
Respiratory rate	Peak inspiratory flow
Minute volume	Peak expiratory flow
Inspiratory time

Cardiac System
Blood pressure	ECG rate and intervals
Blood flow	Contractility

Immunology System
Anti-inflammatory tests	Natural killer cell assay
Cytokine profiling	Peripheral blood differential counts
Cytotoxic T-lymphocyte assay	Antigenicity, Allergenicity and Hypersensitivity Assessment
Macrophage function

Animal Models
Rodent	Porcine
Canine	Non-human Primate