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administration route change (IV to SC)

  • 1.  administration route change (IV to SC)

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jan-2018 11:12
    This message was posted by a user wishing to remain anonymous

    Looking for expert opinions on the clinical bridge studies for the antibody drug switching the administration route from IV to SC in the early development. Our drug has completed the phase 1a study in the healthy volunteers (IV injection). We now have developed the new formulation for SC use.  Since there is no efficacy data collected in the patients yet,our question is if we need any bridge human clinical study (eg. PK study) before the phase 1b/2a or we could use non-clinical study (ex. monkey tox study) to support the SC formulation for next clinical stage? 

    Thank you !
     


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