Proof-of-Concept of a Qualitative qPCR Assay for RCL Monitoring

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qPCR assays for RCL monitoring are a rapid method to detect and usually quantify lentiviral genes, such as the envelope gene vesicular stomatitis virus G…

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In-Cell ELISA Assays to Assess Drug Relative Potency Using the Cytation Imaging Reader for Sample Analysis

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Potency assays are crucial characterization tools for almost all biotherapeutics during clinical and pre-clinical development for quality control and market authorization purposes.

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Points to Consider in the Development of Activity and Potency Assays for Enzyme Biotherapeutics

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The ability of enzymes to remain active outside their source organism makes them an ideal candidate for biotherapeutics.

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Qualification of a Neurology 2-Plex B (Nf-L, GFAP) Quanterix Simoa® Assay Using a Novel Approach

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Biomarkers associated with neurodegenerative diseases and traumatic brain injuries, including Nf-L (Neurofilament light) and GFAP (Glial fibrillary acidic protein) have been identified as potential prognostic…

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Strategy for Assessing Stability in Multiplexed Cytokine Panels

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Clinical trials requiring analysis of more than one biomarker can greatly benefit from implementation of multiplex biomarker panels.

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Potency Assay Development for Gene Therapy Products – Approaches and Points to Consider in Data Processing

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Gene therapies – including AAVs, engineered viruses and polymer formulated oligonucleotides/plasmids – are among the highest growth area in biopharmaceuticals.

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Toxicokinetics of Pirfenidone in Dogs Following Inhalation in a Nebulized Aerosol Formulation

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To assess the toxicokinetics (TK) exposure of pirfenidone (AP01) during a 28-day oronasal dog inhalation toxicity study

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Comparison of the Pharmacokinetics of Four Different Dose- Frequency Combinations of AMZ001 (Diclofenac Gel 3.06%) with Voltaren® (Diclofenac Gel 1%) in Healthy Subjects in a Phase 1 Study

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To evaluate how the steady state levels of AMZ001 applied one or two times daily compare to Voltaren® applied four times daily in healthy subjects.

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Efficient and Economical Preclinical Pharmacokinetic Analyses for Human Therapeutic Antibodies and Constructs, Using a Validated Human Immunoglobulin Immunoassay in Plasma of Mice, Rats, and Monkeys

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This work was conducted to develop and validate (fit-for-purpose, FFP) an efficient means for pharmacokinetic (PK) analyses of large molecule drugs composed in part, or…

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Pirfenidone and its Metabolites 5-Carboxy-Pirfenidone and 5-Hydroxy-Pirfenidone Toxicokinetics in Rats Following Inhalation of a Nebulized Aerosol Formulation

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To assess the toxicokinetics (TK) of pirfenidone (AP01) and its main metabolites 5-carboxy-pirfenidone and 5-hydroxy-pirfenidone during a 26-week oronasal rat inhalation toxicity study.

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