On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Monday, January 13, 2020
Pre-specifications of the statistical analysis plan - story of Ampligen in Chronic Fatigue Syndrome
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In the previous post, 'Pre-specification and SAP', various regulatory guidelines and guidance were cited to demonstrate the import...
2 comments:
Thursday, January 02, 2020
Pre-specification and statistical analysis plan
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For industry-sponsored clinical trials especially those trials for the regulatory submission purpose (i.e., adequate and well-controlled stu...
4 comments:
Wednesday, January 01, 2020
Pediatric Drug Delivery: Challenges And Solutions
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Drug development usually starts with adult patients and then move onto pediatric patients unless the drug is developed only for pediatric ...
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 ...
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