Safety pharmacology satisfies a key requirement in the drug development process, assessing any potential adverse effects that drug candidates may have on the body’s major physiological systems. To this end, the regulatory guidelines (ICH S7A/S7B) require that a core battery of safety pharmacology studies be conducted with an investigational drug before first administration to humans, to analyze the drug’s effect on cardiovascular, respiratory and central nervous system function. The typical core battery of safety pharmacology studies includes:
- Central nervous system studies: Irwin test
- Cardiovascular system studies:
- In conscious or anesthetized animals
- HERG and Purkinje studies (in vitro)
- Respiratory system studies: whole body plethysmography
Vivotecnia continuously incorporates improvements, always trying to deliver optimum service to its customers at a competitive price. This philosophy has led Vivotecnia to further expand its portfolio of safety pharmacology services by adding cardiovascular safety evaluation in conscious telemetry-implanted animals to the already well-established Irwin test. Telemetry systems allow the animal under study to move freely while data are monitored and collected.
The effects of each new substance on other important physiological functions in addition to the three principal physiological systems must also be tested. These tests are based on chemical and PK/PD profile data for the product or on previous preclinical or clinical results, for example, gastrointestinal function (intestinal and colonic transit, gastric emptying, gastric acid secretion) and renal and urogenital function (diuresis and excretion of urinary electrolytes, main urinary parameters, bladder activity).
Equipment and facilities
- Our safety pharmacology facilities make major surgical procedures possible and include custom-built study rooms with remote telemetry monitoring systems.
- Our in-house colonies of preimplanted animals allow you to start studies quickly and meet optimal deadlines.
- Vivotecnia uses state-of- the-art technologies validated in accordance with CFR 21 Part 58 (GLP) and CFR 21 Part 11 requirements to perform safety pharmacology studies quickly and reliably.
Our team and experience
Our safety pharmacology team consists of highly experienced veterinarians and scientists ready to help you reach your goals while ensuring ICH regulatory requirements are met. Vivotecnia can guide you or advise you about the best course of action to meet these requirements.
Vivotecnia personnel have the training and experience necessary to reliably determine the most common endpoints in safety pharmacology studies.
Our experience includes:
- Cardiovascular function integrated in toxicology studies
- Cardiovascular function by telemetry
- Respiratory function using respiratory inductance plethysmography (RIP)
- Central nervous system function using FOB or cognitive testing
- Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals, ICH M3(R2), June 2009
- Preclinical safety evaluation of biotechnology-derived pharmaceuticals, ICH S6(R1), June 2011
- Safety pharmacology studies for human pharmaceuticals, ICH S7A, November 2000
- Nonclinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals, ICH S7B, May 2005
- Nonclinical evaluation for anticancer pharmaceuticals, ICH S9, October 2009
- FDA Guidance for industry, investigators and reviewers on exploratory IND studies, January 2006
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PK/PD and Metabolism
During the drug discovery process, ADME (absorption, distribution, metabolism, and excretion) and PK studies are deemed necessary to evaluate bioavailability.
Inhalation toxicity studies are required to assess the exposure hazards of consumer products or to manufacturing workers.
Vivotecnia offers the Irwin test as a central nervous system study as part of our safety pharmacology services portfolio.
Cardiovascular Safety Pharmacology Studies
Vivotecnia offers in-house colonies of telemetry-implanted animals for fast start-up cardiovascular safety pharmacology studies.