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  • development part ii—conducting abbreviated long-term and accelerated stability testing on the first clinical drug substance batch to confirm and adjust the drug substance retest period/powder for oral solution shelf life

    جزئیات بیشتر مقاله
    • تاریخ ارائه: 1392/07/24
    • تاریخ انتشار در تی پی بین: 1392/07/24
    • تعداد بازدید: 969
    • تعداد پرسش و پاسخ ها: 0
    • شماره تماس دبیرخانه رویداد: -
     in pursuit of continuous process improvement, the authors streamlined the drug substance (ds) stress and stability testing process from preclinical to the first clinical batch. high temperature/high humidity stress and ich q1b confirmatory photostability testing on an early ds batch provide stability data that help quickly assess the new ds stability behavior, extrapolate the initial ds retest period and the initial powder for oral solution (pfos) shelf life, and evaluate packaging requirements. then, concurrent stability testing on the first clinical batch (or alternatively a representative nonclinical batch) is conducted under long-term (lt) and accelerated (ac) storage conditions. the lt/ac stability testing is used to verify the solid stress testing results and to adjust the ds retest period and the shelf life of (pfos), if necessary. this paper describes how to perform abbreviated lt/ac stability testing, compares lt/ac stability results with the solid stress results, shows how to adjust the ds retest period and pfos shelf life if necessary, and shares our regulatory experiences with this new approach. our science- and risk-based ds stress and stability process has offered a quick turnaround in obtaining adequate stability information for new ds development, eliminated redundancies, improved efficiency and consistency, achieved an optimal balance between risk and cost for early drug development, and received regulatory acceptances.

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