Literature
Harlan Laboratories offers a complete range of toxicology
studies to support the world-wide registration of inhaled
pharmaceuticals or chemicals
- Acute toxicity in rodent
- Subacute to subchronic toxicity in rodents and non-rodents
- Chronic toxicity in rodents and non-rodents
- Reproduction and teratogenicity in rats and rabbits
- Carcinogenicity
- ADME and toxicokinetic studies can be performed in
rodents and dogs using radiolabelled test items
- Safety pharmacology studies can be performed according to ICH
S7A guidelines.
Harlan Laboratories is one of the few facilities that combines
inhalation dosing expertise with general and reproductive
toxicology and pharmacology. Various aerosol generation methods are
employed at Harlan Laboratories, the choice of test system being
dependent on the physical characteristics of the test item. Systems
include the use of double brush-feed and piston-feed generators,
with or without a jet-mill microniser, for dry powders; nebulisers
for liquids and specialised equipment for the administration of
gases and test compounds administered by metered dose inhaler
(MDI).
Studies are performed in purpose-built laboratories with on-line
facilities for data capture from animals and exposure
systems.
Specialised exposure methods are available for rodents, rabbits
and dogs. In rodents and rabbits the use of a positive-feed, flow
past, nose-only system ensures that all animals receive a
consistent concentration of ’fresh’ aerosol throughout the
exposure. For dogs, a muzzle-only exposure system based on similar
principles is routinely used. Each inhalation system can be adapted
for use with dry powders, liquids or gases (i.e. CFC-replacement
propellants) taking into consideration the biological, physical and
chemical properties of each test item. Inhalation studies are
perfomed in rodents for up to two years and in dogs for up to one
year.