During the preclinical stage, studies in animal models are combined with cellular and biochemical assays to understand the effects of lead drug candidates and provide detailed reporting on the pharmacological profile, acute toxicity in at least two animal species, and short-term toxicity studies. Early dosage studies are also performed to guide the implementation of subsequent clinical phases. Show more
Testing includes the pharmacology of absorption, distribution, metabolism, and excretion (ADME), metabolic stability, pharmacokinetics, immunogenicity/ADA, biomarker analysis, and the mutagenicity, reproductive effects, and in vitro and in vivo toxicity of candidates and their metabolites. Data from this phase are used to determine whether to proceed to human testing, and the no observable adverse effect levels (NOAELs) are used to guide starting dosages in clinical trials. Show less
Featured VideoDevelopment of Recombinant Antibodies for PK/PD and Immunogenicity Assays
Rapidly evaluate responses in metabolic, signaling, and other biological pathways and characterize mutagenesis with predesigned, validated qPCR and Droplet Digital™ PCR Assays and automated real-time PCR systems and ddPCR™ Systems.
Droplet Digital PCR Systems Real-Time PCR Automation
Develop large-scale purification strategies for your protein or antibody drug using our range of chromatography resins (media).
NGC™ Medium-Pressure Chromatography Systems Chromatography Columns and Resins
Explore our tools and assays for the identification, and analysis of protein profiles to support ADME and biomarker studies.
Multiplex Cancer Immunoassays Western Blotting Reagents and Equipment
Develop robust cell-based screening assays using our quick and efficient cell counting, cell sorting, and flow cytometry instrumentation. Our comprehensive range of antibodies and custom options allows you to monitor safety, ADME, and toxicity with ease.
Cell ImagingCell Counting Cell Sorting and Flow Cytometry Antibodies for Flow Cytometry
Choose from an extensive range of antibodies for use in your preclinical testing assays or utilize our custom antibody services.
Antibodies by Application Antibodies by Target Species Cell Signaling Antibodies HuCAL® Custom Antibody Services
Biomarker DiscoveryThe use of biomarkers across drug discovery and development and into the clinic is key to enabling close monitoring of a drug candidate’s effects. Biomarkers can range from specific molecules such as a protein, a gene sequence, or expressed RNA to physiological parameters such as blood pressure. Biomarkers may be detected in a specific location or tissue or in plasma and other bodily fluids.
Biochemical and Cellular AssaysBiochemical and cellular pharmacology teams develop and validate assays to support research across drug discovery and development. These assays range from discovery approaches with high sample throughput to high-content analysis to gain an understanding of biological response both in vitro and in vivo.
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