Friday, December 27, 2019

Determining the Dose in Clinical Trials: ED50, NOAEL, MTD, RP2D, MRSD, RP2D, MinED,

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After a new compound is discovered, a series of pre-clinical and clinical studies need to be conducted to identify the suitable dose for cl...
Thursday, December 26, 2019

Basket Trial: challenges and disadvantages

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With the advances in biomarker identification and precision medicine, the biomarker-based clinical trial design becomes a new trend. In 20...
Friday, November 22, 2019

CAR T-Cell Therapies: Current Limitations & Future Opportunities

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CAR-T therapies have been a hot area right now. Pharmaceutical companies and biotechnology companies are all trying to jump into the CAR-T ...
Sunday, November 17, 2019

Dilemma in Withdrawing a Drug Approved Through Accelerated Approval Pathway

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Last week, NPR reported that premature birth medication Makena did not work and debate was on whether the Makena should be pulled from the m...
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Monday, November 11, 2019

Breakthrough or Political Pressure: GV-971 and aducanumab for treatment of Alzheimer's Disease

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Recently, we saw the breakthroughs in drug development for Alzheimer disease. The Chinese regulatory authority (NMPA) approved GV-971 (Oli...
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Monday, October 14, 2019

A clinical trial with sample size = 1?

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In the October issue of New England Journal of Medicine, Kim and Hu et al from Boston Children's Hospital published a paper " Patie...
Sunday, October 13, 2019

Real-World Evidence for Regulatory Decision Making - Some Updates

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This year, real-world data and real-world evidence is the theme in every conference in the clinical trial and drug development area. Just a ...
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