Monday, December 28, 2020

120-Day Safety Update or 4-Month Safety Update - The Requirement for NDA/BLA

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After the new drug application (NDA) or biological license application (BLA) is submitted by the sponsor and is accepted by FDA, FDA reviewe...
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Tuesday, December 08, 2020

COA (Clinical Outcome Assessment): PRO, ClinRO, PerfRO, ObsRO, eCOA, and TECOA

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Clinical Outcome Assessment (COA) has triggered multiple acronyms: PRO, ClinRO, PerfRO, and ObsRO According to FDA's website , these acr...
Sunday, December 06, 2020

Multiple Imputation: Imputation Model versus Analysis Model

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Multiple imputation has become more and more popular in handling the missing data in clinical trials. Multiple imputation inference involves...
Sunday, November 29, 2020

Handling of Missing Data: Comparison of MMRM (mixed model repeated measures) versus MI (multiple imputation)

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Longitudinal study has become one of the most commonly adopted designs in clinical trials. Since the outcome measures are performed at vario...
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Saturday, November 14, 2020

Words Ended with '-demic': Pandemic, Epidemic, Endemic, Twindemic, and Infodemic

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This year during the COVID-19, we hear enough words ended with '-demic', some are old and some are new. A usual saying is that ...
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Saturday, November 07, 2020

The Saga of Biogen’s Alzheimer Drug Aducanumab

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Aducanumab is an investigational compound being studied for the treatment of early Alzheimer’s disease co-developed by Biogen and Eisai. Adu...