Bioanalysis

  • Bioanalysis
  • Mitigation of On-Column Conversion of Ivabradine to Desmethylivabradine Metal Chelation With Citric Acid Modifier

    Dual Purpose of a Cell-Based Assay for an Agonist of the GLP-2 Receptor

    Development of an Oligonucleotide Drug Immunogenicity Assay: A Case for the Characterization of the Immune Response

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    Bringing new drugs to market, from lead candidate selection through preclinical testing, to clinical proof of concept, is a complex, time-consuming, and costly process.

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    Early-phase drug discovery and drug development are complex processes, where many moving parts can, and do, influence the success of a program.

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    In a previous blog, we provided an overview of microsampling technology for preclinica

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    Renowned for our full-service offering, we often get asked — how does Altasciences manage the development process for biologics and biosimilars so seamlessly from the require

    Microsampling significantly lessens the volume of blood and plasma/serum that is collected and analyzed to determine circulating concentrations of therapeutic drugs, metabolites, and biomarkers in preclinical and clinical research.

    In preclinical research, microsampling technology supports the 3Rs of animal research, and allows for less intrusive blood collection procedures.

    By definition, clinical microsampling reduces sample volume to less than or equal to 50 microlitres (μL) compared to conventional venipuncture wherein millilitres (mL) of blood volume is collected. In Altasciences’ experience, microsample volumes being analyzed are less than or equal to 20 μL, with some microsampling techniques as low as 5 μL.

    In Issue 16 of The Altascientist, we explore the benefits, applications, and considerations of microsampling in preclinical, clinical, and bioanalytical research, including:

    • regulatory considerations
    • case study: Anti-Epileptic Drug Monitoring – Sample Preparation Using Impact-Assisted Extraction
    • case study: Large Molecule – Determination of Rituximab Using a Surrogate Peptide Approach

     

     

    2020 has been quite a year! Each year, we strive to provide you with a more innovative, simplified, and seamless early phase drug development journey. And the past 12 months have been no exception.
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    Dr.

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