Harlan Laboratories performs all metabolism studies necessary to characterize the absorption, tissue distribution and depletion, metabolism and elimination profiles in vivo and in vitro to interpret toxicological findings. Harlan Laboratories supports all phases of the discovery and development pipeline. These include pharmacokinetic and/or toxicokinetic profiling, mass balance and distribution studies, including the profiling and identification of excreted and circulating metabolites with radio-chromatography, LC-MS/MS (triple quadrupoles), ion-trap, ultra high resolution MaXis TOF-MS, and NMR.
- Mass balance studies (absorption and excretion)
- Pharmacokinetic and toxicokinetic profiling
- Bioavailability and bioequivalence
- Tissue distribution and elimination kinetics
- Accumulation and elimination kinetics after multiple dosing regimen
- Quantitative Whole Body Autoradiography (QWBA)
- Biliary excretion
- Placental and milk transfer
- Dermal penetration in vitro and in vivo
- Metabolism in vitro and in vivo
- Metabolite profiling in excreta and tissues residues
- Metabolite characterization and identification
- Protein binding, blood/plasma partition
- CYP-profiles, drug-drug interactions
- Radio-analytical support of clinical trials
Radiolabeled materials
We are able to undertake studies with the following labeled materials:
14C, 3H, 35S and 125I
Routes of administration
- Oral (gavage)
- Oral (feeding)
- Subcutaneous
- Intravenous
- Intratracheal
- Dermal
- Intramuscular
- Intraperitoneal
Species
- Rat
- Dog
- Mouse
- Monkey
- Hamster
- Rabbit
- Mini pig
Analytics and Metabolite Identification
- Radio-HPLC, Radio-TLC
- Metabolite identification by LC-MS/MS, NMR, ion-trap and co-chromatography
- Accurate mass determination: Bruker MaXis TOF-MS