In Vivo Studies
Vivotecnia can offer you customized early Non-GLP toxicology in vivo studies to support comparison and selection of your potential lead candidates and drive the design of. Although these early studies are not required to be reported to the regulatory agencies prior to First Time In Human studies, we understand that toxicology needs to be fully integrated into the discovery process to allow the selection of candidates with the optimal toxicological properties, making informed decisions quickly, at reduced cost.
Vivotecnia offers exploratory studies od compounds administered by a wide range of routes and animals species including rodents, rabbits, dogs, minipigs, and NHP.
- Acute Toxicity Studies
- Maximun Tolerated Dose Studies
- 7/14 day Dose Range Finding Studies
- Repeated Dose Toxicity Study (up to 52 weeks)
- Multispecies pharmacokinetics (PK) and Toxicokinetics (TK).
Our team and Experience
- Our team of experts functions as an extension of our clients’ R&D team by providing expertise and active management of toxicology services to provide seamless integration between discovery and development programs. We work in an effective, flexible, reliable, and timely manner and identify the appropriate exploratory toxicology program for your unique situation.Our highly specialized staff of Study Directors are trained scientists themselves with a deep knowledge of the drug development industry, interested in understanding and getting involve in the science and methods behind innovations including medical products, devices, drugs and biologics across a wide range of therapeutic areas.Vivotecnia Research Exploratory Toxicology programs advantages include:
- Protocol development & Regulatory Guidance.
- Availability of animal models for preclinical trials (Rodent and non-rodent).
- Multispecies pharmacokinetics (PK) & toxicokinetics (TK) via a wide range of administration routes.
- Toxicology, Feed, Nutrition & Range finding studies.
- Surgical Research Facilities (ideal for surgical devices & implants).
- Competitive Pricing.
- Expeditious Turnaround Time.
- ICH M3(R2) – Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and
Marketing Authorization for Pharmaceuticals.
- National Centre for the Replacement, Refinement and Reduction of Animals in Research. Challenging
Requirements for Acute Toxicity Studies: Workshop Report; 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
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