Study DesignTo Top

Partnering with sponsors to create customized study protocols, NBR can recommend study designs while taking into consideration routes of administration, test article characteristics, animal models and individual needs of the sponsor. NBR scientists have extensive experience performing complex GLP studies while remaining flexible to unexpected changes to study protocols.

Dose AdministrationTo Top

Single or multiple doses can be administered as a bolus, short or long duration infusion, or continuous infusion. Doses can be administered via a CNS-implanted catheter that terminates in a subcutaneous access port, implantable osmotic or mechanical infusion pump, or an external infusion pump. Dual catheterization (for dose administration and CSF sample collection) is available for non-human primate, canine and ovine models. Traditional routes of administration (oral, parenteral, etc.) are also available.

PK, TK, Antibody and Naive SamplesTo Top

Serial blood and CSF sample collections, including continuous CSF collections in rats, at protocol-determined time points allow determination of pharmacokinetic (PK) and toxicokinetic (TK) parameters, modeling and antibody (Ab) analysis. CSF samples can be collected from non-human primate, rodent, canine or ovine models via a lumbar or cisterna magna tap or a CNS-implanted catheter that terminates in a subcutaneous access port.

Naive samples (CSF, serum, plasma and tissues) from non-human primates, canines, sheep and rats are available upon request for method development.

 

In Life MeasurementsTo Top

  • Clinical Observation
  • Food/Water Consumption
  • Body Weight
  • Neurological, Physical and Behavioral Assessment
  • Ophthalmology
  • Electrophysiology (ECG and EEG)
  • Clinical Pathology
    • Blood: Clinical Chemistry, Coagulation, Hematology
    • CSF: Chemistry, Total Cell Count
    • Urinalysis

Necropsy and HistopathologyTo Top

Full necropsy services are available, including whole-body perfusion, prosection, tissue trimming, organ weights, and custom tissue sampling (including CNS tissue samples). Special fixatives are available. Histopathology services are contracted with companies offering neuropathology, neurohistology and immunohistochemistry services.

Quality AssuranceTo Top

A quality assurance unit is available on-site to ensure study GLP compliance and adherence to the protocol and SOPs.