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How can modelling ensure enough exposure in SAD? – a case study of administration optimization

  • At: 2017 FIP Congress in Stockholm (Sweden)
  • Type: Poster
  • By: CARLERT, Sara (AstraZeneca, Pharmaceutical Sciences, Mölndal, Sweden)
  • Co-author(s): Sara Carlert: Pharmaceutical Sciences, AstraZeneca, Mölndal, Sweden
    Christer Tannergren: Pharmaceutical Technology and Development, AstraZeneca, Mölndal, Sweden
  • Abstract:

    Backgrounds

    Escalating single dose studies of AZ1 showed limitations in exposure above doses of 200 mg that were likely solubility related, which could potentially jeopardize the future clinical study plan. Time delays for more than a couple of weeks were not permitted, which excluded reformulation of the drug.

    Aims

    The challenge was to create a new

    ..

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Last update 4 October 2019

FIP Congresses