DMPK in-vivo Services Subhead Needed 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 Our drug metabolism and pharmacokinetics experts reliably quantify and interpret results to put IND-enabling programs on the fast track.