ABC Laboratories provides GLP services for PK, ADME and bioanalysis to support IND-enabling programs. Our unique combination of radio-labeling expertise, in-vivo DMPK study design and execution, and partnerships with neighboring AALAC-accredited animal research facilities streamlines preclinical studies, expediting the path to first-in-human studies.
Once a compound advances to the clinic, we reliably deliver rapid turnaround of total radioactivity data for human mass balance studies, minimizing patients' time in the clinic, and provide responsive bioanalytical testing support throughout all phases of clinical programs.
Drug Discovery/Development
- Radiolabeled or Non-Radiolabeled Test Compounds
- Dose Analysis (Radiochemical Purity, Specific Activity)
- Mass Balance/Excretion (14C & 3H)
- Placental & Lacteal Transfer (rat, rabbit)
- Biliary Excretion (mouse, rat, dog and monkey)
- Enterohepatic Recirculation
- Bioequivalence & Bioavailability
- QWBA (Subcontracted)
- Metabolite Characterization & Identification
Pharmacokinetics/Toxicokinetics
- Single or multiple dosing (in-life)
- Analytical (method development, validation and sample analysis)
- PK/TK/PD Analysis
Radiolabeled Mass Balance Studies (Animal & Human)
- Mass Balance
- Metabolite Profiling & Identification
- Proposed Metabolic Pathway
Data Acquisition/Reporting
- Analyst
- Win NonLin
- Sigmastat
- Empower 2
- Daily backup of raw data
- Detailed, customized reports & electronic reporting available