Safety Pharmacology satisfies a key requirement in the process of a drug development, assessing the potential adverse effects of drug candidates on the major physiological systems of the body. A core battery of Safety Pharmacology tests are required by international regulatory guidelines (ICH S7A/S7B) prior to initiation of the first human dose of an investigational medicine, including cardiovascular function, respiratory function, and CNS behavior.
Typically a core battery of Safety Pharmacology includes:
- Central nervous system studies: Irwin test
- Cardiovascular studies:
- In conscious or anesthetized animals
- HERG and Purkinje studies (in vitro)
- Respiratory studies: whole body plethysmography.
Vivotecnia is always involved in a continuous trend of improvements, striving to provide its customers with the best performance at competitive prices. Following this philosophy, Vivotecnia has further expanded its safety pharma portfolio and has added to its established Irwin test, the cardiovascular safety assessment in conscious telemetry-implanted animals. The telemetry system allows the animals to move freely while monitoring and collecting all data.
In addition to the three main vital systems (Central Nervous, Cardiovascular and Respiratory Systems), the effects of a test substance on other important physiological functions should be assessed on the basis of its known chemistry, PK/PD or previously reported preclinical or clinical effects: i.e. Gastrointestinal (intestinal and colonic transit, gastric emptying, gastric acid secretion, …) and Renal & Urogenital (diuresis and urinary electrolytes excretion, main urinary parameters, bladder activity…).
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Safety studies are essential to assess adverse effects of new candidates
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