Preclinical
Drug Development Services Phase I-III
Bioanalycal Method Development, Validaon & Roune Analysis BioAssay & Cell-based Potency Assay
Bioanalycal Method Development & Validaon* DMPK / ADME / Mass Balance Studies
Bioavailability, Bioequivalency & Drug Interference* Quantave Analysis of Drug & Metabolites* Metabolite ID
Dose Formulaon Tesng Clinical Sampling Kits
Analycal Method Development & Validaon for Drug Substance & Drug Product Analycal & Stability Tesng of Engineering Batches
Analycal Support for In-Process Tesng Drug Substance and Drug Product Safety/Immunogenicity Tesng
Stability Tesng & Storage on Drug Substance & Drug Product Reference Standard Synthesis, Management, Characterizaon & Storage Extractables & Leachables
Isolaon, ID and Characterizaon of Trace / Process Impuries Container / Closure Qualificaon*
Compability Tesng
Degradaon Pathway Studies QC / Release Tesng
Metals Analysis by ICP-MS GLP/CGMP API Synthesis w/COA, Radiolabeling & Custom Synthesis (including <kg Reference Standards) Environmental Assessment, Physical/Chemical Properes, Environmental Fate
KEY
Small Molecule Large Molecule
Small & Large Molecule 4780 Discovery Drive
www.abclabs.com • Columbia, Missouri 65201 • (855) 699-3109
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