Articles with "bridging study" as a keyword



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Response to Comment on ‘Statistical Consideration and Challenges in Bridging Study of Personalized Medicine’: A modified variance for sensitivity

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Published in 2022 at "Journal of Biopharmaceutical Statistics"

DOI: 10.1080/10543406.2022.2065876

Abstract: Dear Editor, In my original paper of the bridging study, the estimates of mean and variance for the treatment efficacy for CDx+ patient population are assumed to be independent, a typical assumption for an independent… read more here.

Keywords: mean variance; bridging study; variance; medicine ... See more keywords
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A Randomized, Open-label, Two-period Crossover Bridging Study on Fuzuloparib Capsules of Different Specifications in Healthy Chinese Volunteers.

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Published in 2021 at "British journal of clinical pharmacology"

DOI: 10.1111/bcp.15035

Abstract: INTRODUCTION Fuzuloparib, also known as fluzoparib or SHR3162, is a poly ADP-ribose polymerase (PARP) inhibitor developed for the treatment of malignant tumor. Three specifications of fuzuloparib capsules (10mg, 40mg and 100mg) were originally developed for… read more here.

Keywords: randomized open; fuzuloparib capsules; period; study ... See more keywords