Preclinical Research

  • Preclinical Research
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    The 3Rs of Animal Research

    The 3Rs philosophy is the guiding principle for the Animal Welfare Program at Altasciences.

    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.

    Snuggle Wrap-based Restraint Method of Continuous Infusion in Juvenile Nonhuman Primates

    Historical Control Database of Cynomolgus Macaque Spermatozoa

    Assessment of Subcutaneous Radio-Telepathy Device Implantation in Cynomolgus Monkeys

    Intraperitoneal Alfaxalone and Alfaxalone–Dexmedetomidine Anesthesia in Sprague–Dawley Rats (Rattus norvegicus)

    As you work towards a successful New Drug Application (NDA) submission, there are many considerations that must be taken into account, specifically for central nervous system (CNS)-active drugs. Molecules or compounds that are centrally active (the parent drug or metabolite[s]), may require additional evaluations to characterize the drug effects and unique safety characteristics.

    Not all centrally acting drugs require additional assessments; however, strategic direction early in a drug development program can help determine whether such studies should be planned or can be waived.  

    In Issue 14 of The Altascientist, we look into the complex considerations of CNS-active drugs, including:

    • The landscape of CNS-active drug studies
    • Drug scheduling and the Controlled Substances Act (CSA)
    • Reviewing data from early-phase preclinical and clinical studies
    • Choosing a CRO for CNS studies
     

     

    THE IMPORTANCE OF CLINICAL STUDIES FOR CNS-ACTIVE DRUGS

    CNS-active drugs have unique attributes that necessitate additional specialized study, such as:

    Determination of Pirfenidone and Metabolites in Rat Plasma by Coupling On-Line Fractionation with LC-MS-MS

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    Microsampling volume

    Blood microsampling is a less invasive and simplified alternative to traditional venipuncture, and provides significant ad

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