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Preclinical and Clinical Development

The preclinical development phase typically involves early safety and efficacy investigations using in vitro, in silico, and animal model studies and is followed by clinical trials to establish safety, dose requirements, and efficacy. 

Key data are obtained from toxicology studies, drug metabolism, and pharmacokinetic (DMPK) studies.

We offer Whatman FTA DMPK cards for the collection and storage of small volumes of blood using the dried blood spot method. These cards allow you to make more tests, using individual animals for preclinical testing and achieving better quality PK/PD/TK data, to ensure that you get the most out of your experiments. In addition, we also supply Anopore membranes for liposome extrusion.

Biacore SPR Systems Whatman FTA DMPK Cards Cytiva Human Cell Models Downloads

Biacore Surface Plasmon Resonance (SPR) Systems

Label-free compound screening and characterization using Biacore systems can readily accommodate early, in vitro ADME-indicating analyses such as compound binding to multiple plasma proteins (% bound) and binding to liposomes of different compositions (fraction absorbed [Fa]). The benefits of these ADME-indicating assays are their convenience, high resolution, and low sample consumption.

Immunogenicity Studies

For biotherapeutics, host-produced anti-drug antibodies (ADAs) are closely monitored because they may reduce the efficacy and lead to the buildup of a life-threatening immune reaction. Biacore systems offer comprehensive analysis of immune response in serum samples, providing information on isotype, specificity, kinetic profiles, and affinity (pharmacodynamics). Biacore systems reliably detect low affinity antibodies frequently displayed in early immune response, which other technologies might miss.

Whatman FTA DMPK Dried Blood Spot Sampling Cards

Drug metabolism (DM), pharmacokinetic (PK) and toxicokinetic (TK) studies typically require composite sampling, which results in lower quality data and an increase in the number of animals used. In contrast, dried blood spot microvolume sampling using Whatman FTA DMPK Cards will allow you to make more tests, using individual animals, achieving better quality PK/PD/TK data to ensure that you get the most out of your experiments.

Cytiva Human Cardiomyocytes

Cardiotoxicity and hepatotoxicity are common causes of drug safety liabilities and withdrawal of drugs during development. Cytiva Cardiomyocytes are derived from NIH-approved human embryonic stem (hES) cells and provide an abundant and reliable source of biologically-relevant cells for cardiac safety and toxicity testing.

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