In Vivo Studies
Vivotecnia will create customized early non-GLP in vivo toxicology studies for you to support comparison and selection of your potential lead candidates and to guide the design of further studies. Although these preliminary in vivo studies are not subject to regulatory reporting prior to first-in-human studies, we comprehend that toxicology needs to be fully integrated into the discovery process to select candidates with optimal toxicological profiles, to make informed decisions quickly and to reduce costs.
Vivotecnia offers exploratory in vivo studies of compounds administered by a wide choice of routes to numerous animal species including rodents, rabbits, dogs, minipigs, and NHPs.
- Acute toxicity studies
- Maximum-tolerated-dose studies
- 7- or 14-day dose-range-finding studies
- Repeated-dose toxicity studies (up to 52 weeks)
- Multispecies pharmacokinetics (PK) and toxicokinetics (TK)
Our team and experience
Our team of experts acts as an extension of your R&D team by providing expertise and active management of toxicology services to provide seamless integration between discovery and development programs. We work effectively, flexibly, reliably, and expeditiously to identify an appropriate exploratory toxicology program for your unique situation. Our highly specialized staff of study directors are trained scientists with an in-depth knowledge of the drug development industry. They are eager to understand and get involved in the science and methods behind innovations, whether medical products, devices, drugs or biologics across a wide range of therapeutic areas.
Vivotecnia’s research exploratory toxicology program’s advantages include:
- Protocol development and regulatory guidance
- Animal models available for preclinical trials (rodent and nonrodent)
- Multispecies pharmacokinetics (PK) and toxicokinetics (TK) with a wide selection of administration routes
- Toxicology, feed, nutrition, and range-finding studies
- Surgical research facilities (ideal for surgical devices and implants)
- Competitive pricing
- Prompt turnaround time
- Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals, ICH M3(R2), June 2009
- Challenging the regulatory requirement for acute toxicity studies in the development of new medicines: A workshop report, National Centre for the Replacement, Refinement and Reduction of Animals in Research, May 2007
- Robinson S, et al. A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development. Regul Toxicol Pharmacol, (2008) Apr;50(3):345-52
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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
Our team of experienced, highly-educated scientists, experts in toxicology, molecular biology, chemistry and immunology fully understands that the drug development process is distinct for each approach.
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.