Pharmacology is the study of the mechanism by which substances act on a living
system. All drugs or new chemical entities (NCE's) undergo safety pharmacology
screening to provide an assessment of the pharmacological profile in areas other
than the intended therapeutic use. We run study types identified in the ICH
(International Conference on Harmonisation) guideline on safety pharmacology
studies for human pharmaceuticals (S7A and S7B- draft).
A core battery set of studies was designed to investigate effects on vital
organ systems such as the Central Nervous System (CNS), Cardiovascular (CV)
and Respiratory system.
- CNS - Modified Irwin dose-range
- CV - Telemetry (BP, HR, ECG) in a non-rodent species
- Respiration - Rate, tidal volume and minute volume
- In vitro hERG ion channel assay and Action Potential measurement
are available if required
Depending on the outcome of the core battery studies, additional follow-up studies may be required.
Further studies may also be required based on the therapeutic target or previous work done on similar classes of compound.
- Renal / urinary system
- Gastro-intestinal system
- Dependency potential
- Electrophysiology
- Autonomic nervous system and smooth muscle
- Neuromuscular function
- Assessment of antigenicity
- Endocrine function
- Other studies - e.g. drug interaction, measurement of blood parameters
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