Preclinical & Nonclinical Safety


 
LRRI offers complete standard study designs that meet FDA, ICH, MoHW or OECD guidelines, as well as customized study designs to meet a sponsor's special needs. Studies are run in strict compliance with Good Laboratory Practices (GLPs).
 

 

LRRI has over 25 years of experience in conducting GLP toxicology studies. We are proud of our team approach (sponsors are an integral component) in study design, conduct, and report preparation. Toxicologists (five PhD, DABT), pathologists (four DVM, DAVCP), and a highly qualified technical staff are available to conduct your studies.

LRRI has extensive experience conducting toxicokinetic (TK) and pharmacokinetic (PK) studies. Our staff has investigated a wide variety of small molecule drugs and biopharmaceuticals. We offer analytical method development and validation to identify and quantitate test articles, metabolites, and degradation products in dose preparations, exposure atmospheres, and biological specimens using HPLC, LC/MS and LC/MS/MS instrumentation. Also, we have full in-house capabilities in clinical and anatomic pathology including full histopathology, special stains, immunohistochemistry, and morphometry. Our animal facilities are AAALAC-accredited.

Key Capabilites:

  • Inhalation (nose-only, head-only, or whole-body)
  • Nasal mucosa, nasal cavity, or intratracheal
  • Oral or nasogastric
  • Arterial (hepatic artery, carotid artery, or femoral artery)
  • Intravenous (bolus, intermittent infusion, or continuous infusion)
  • Intramuscular or intraperitoneal
  • Percutaneous, subcutaneous, or intradermal
  • Ocular
  • Intracerebral or intraventricular

LRRI has an international reputation for high-quality inhalation toxicological evaluation.