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…).
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 pre-instrumented animals allow you to start studies quickly and meet
- Vivotecnia uses state-of- the-art technologies validated following CFR 21 Part 58 (GLP) and CFR 21
Part 11 requirements to perform safety pharmacology studies in a fast and reliable manner.
Our team and Experience
Safety Pharmacology team is made up of highly-experienced veterinarians and scientists who are there
to help you to reach your goals while ensuring ICH regulatory requirements are met. Vivotecnia can give
guidance about the best steps to be taken to meet these requirements.
Vivotecnia personnel have the training and the experience needed to reliably determine the following
common endpoints in Safety Pharmacology studies.
Our experience includes:
- Cardiovascular function integrated in toxicology studies
- Cardiovascular function by telemetry
- Respiratory function using Respiratory Inductive Plethysmography (RIP) approaches
- Central Nervous System function using FOB or congnitive testing
- ICH Harmonised Tripartite Guideline (ICH M3 (R2): Guidance on non-clinical Safety Studies for the
conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
- ICH Harmonised Tripartite Guideline (ICH S6; R1): Preclinical safety evaluation of biotechnology-
derived pharmaceuticals. Jun 2011
- ICH Harmonised Tripartite Guideline (ICH S7A): Safety pharmacology studies for human
pharmaceuticals. Nov 2000
- ICH Harmonised Tripartite Guideline (ICH S7B): The non-clinical evaluation of the potential for
delayed ventricular repolarization (qt interval prolongation) by human pharmaceuticals
- ICH Harmonised Tripartite Guideline (ICH S9): Nonclinical evaluation for anticancer pharmaceuticals.
- FDA Guidance on Exploratory IND studies. Jan 2006
For more information or a formal request, please send us a message and we will contact you.
Maybe you are interested in…
PK/PD and Metabolism
Over the drug discovery process, ADME (Absorption, Distribution, Metabolism, and Elimination) and PK studies are deemed necessary to evaluate the bioavailability…
Inhalation toxicity studies are required to assess the exposure hazards for consumer products or manufacturing workers.
Vivotecnia offers Irwin Test as central nervous system study, which is included in 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.