Bioanalysis

  • Bioanalysis
  • Retrospective Safety Evaluation of Tyrosine Kinase Inhibitor Products When Administered in Single Dose in Crossover Studies to Healthy Volunteers

    Quantitation of Bemnifosbuvir and Metabolites in Human Bronchoalveolar Lavage by LC-MS/MS

    The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines. The goal is to safely incorporate genetic alterations to restore and repair the proteins of missing and/or faulty genes. Gene therapy requires DNA and/or RNA delivery and analysis, and while most ongoing research involves therapies being delivered in vivo via adeno-associated viral (AAV) vectors, other in vivo delivery methods are on the rise.

    Quantitative, digital, and reverse transcription polymerase chain reactions (qPCR, dPCR, and RT-PCR, respectively) are fast and cost-effective techniques employed by Altasciences. These methods are invaluable for quantitative analysis of gene expression and for analyzing genetic variation in amplified DNA and RNA. This ability to analyze variation from limited samples has made genetic diagnosis easier than ever. But how are PCR analysis techniques applied? And how are they incorporated into studies?

    Issue 37 of The Altascientist takes a closer look at these techniques, with in-depth information on:

    • qPCR, dPCR, and RT-PCR and their utilities—including droplet digital PCR (ddPCR);
    • regulatory considerations;
    • PCR applications, advantages, and comparisons; and
    • case studies.

     

     

    Altasciences' Facilities: Moving in Unison

    Choosing the right bioanalytical platform for your molecule’s intended use and program segment is crucial to obtaining reliable, robust data in a timely manner.

    Microsampling for Pediatric Baricitinib Pharmacokinetics

    Accurate Quantification of ASOs in Mouse Serum Using Microsampling LC-MS/MS

    Design and Validation of a Bioanalytical Method to Support a Clinical Pharmacokinetic Study Involving the Use of Multiple Lots of the Biological Therapeutic Drug

    Since 2004, the average cost of bringing a new drug to market has increased from $800 million to about $2.6 billion, without, for the most part, shorter development time

    Application of Mitra Microsampling for the Quantitative Bioanalysis of Antisense Oligonucleotides

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