Auditory Safety and Efficacy

CBI has demonstrated expertise in preclinical contract otic studies — studies relating to the ear. Our highly specialized staff is experienced in providing exploratory and proof-of-concept, and GLP toxicology and pharmacokinetics studies as well as in vivo animal models, pharmacology and histopathology/immunohistochemistry services associated with the outer, middle and inner ear.

We have conducted numerous studies relating to new therapeutics that prevent hearing damage from such concerns as loud sounds, battlefield injuries, ear infections, parasitism, chemotherapeutics, antibiotics, acute and chronic tympanic membrane perforations and surgical manipulations. We have worked with drug delivery systems, which include systemic, local to the ear canal or tympanic membrane or by infusion into the middle or inner ear. Special techniques include peri-lymph collection, cytocochleograms, hair cell analysis, behavioral analysis and auditory brainstem response testing (ABR).

CBI is one of few CRO’s to provide specialty pre-clinical IND enabling GLP or non-GLP Otic and Auditory Toxicology, Efficacy and PK/PD studies in relevant animal species.

 

Otic Services

  • Otic modeling and pharmacology
  • Auditory safety
  • Otic pharmacokinetics studies
  • Otic toxicology studies
  • Peri-lymph collection
  • Peri-lymph pharmacokinetics

Learn more about our Otic Studies:

Download our presentation

AUDITORY ANIMAL MODELS

  • Ear drum, tympanic membrane perforation
  • Bacterial and fungal Infections of external, middle or inner ear
  • Aminoglycoside toxicity
  • Drug or test article toxicity or effects
  • Acoustical hearing loss
  • Inflammation or injury to external ear
  • Parasitism
  • Genetic abnormalities
  • Otic devices, delivery devices
  • Otic anesthesia
  • Unique or customized studies
  • FDA driven studies

TOXICOLOGY

  • Pilot DRF, acute, and chronic toxicology studies
  • Intra-aural, systemic administration and device administration
  • Combination toxicology-device, drug, biologic
  • PK or TK blood, fluid and perilymph assessment
  • Full Histopathology services by ACVP Pathologist
  • Unique or customized studies
  • FDA driven studies

PHARMACOKINETICS

  • Intra-aural and systemic administration
  • Otic devices
  • Perilymph, blood & fluid monitoring
  • Bio-analytical services and method development/transfer

SPECIALIZED TECHNIQUES

  • Auditory Brainstem Response Testing
  • Hair Cell Assessment
  • Cytocochleograms
  • Histopathology, Immunohistochemistry, Histomorphometry
  • Otoscopy and photography
  • Perilymph collection
  • Clinical and CNS in life assessments

DRUG DELIVERY CAPABILITIES

  • Topical application to ear canal-tympanic membrane
  • Inner ear surgical catheterization
  • Infusion into middle or inner ear
  • Systemic administration
  • Device delivery

SPECIES

  • Mice and rats
  • Guinea Pigs
  • Chinchilla
  • Cats, dogs, minipigs

Histological section of rat cochlea tissues at 20x magnification.