On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Showing posts with label
phase I
.
Show all posts
Showing posts with label
phase I
.
Show all posts
Sunday, June 19, 2022
Sentinel Dosing (Sentinel Subject) and Staggering Enrollment in First-in-Human (FIH) Clinical Trials
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First-in-human (FIH) study is a type of clinical trial in which a new drug, procedure, or treatment is tested in humans for the first time. ...
Monday, February 28, 2022
Human Preclinical Studies and Phase 0 Clinical Trials
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The drug development process includes various steps from discovery (discovery of a new compound or biological product) to preclinical resear...
4 comments:
Friday, October 08, 2021
Serial Blood Sample Timepoints for Comparing Pharmacokinetics Profiles Between Two Different Dose Frequencies
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It is very common in the drug development process that the dosing frequency needs to be studied. The dosing frequency is usually based on th...
Sunday, July 25, 2021
Maximum Tolerable Dose (MTD) and Dose-Limiting Toxicities (DLTs)
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According to Wiley Encyclopedia of Clinical Trials, the maximum tolerable dose (MTD) is defined as: The “Maximum Tolerable Dose” (MTD), a...
Sunday, June 20, 2021
Early Phase Trial to Find Maximal Tolerated Dose (MTD) - 3+3, CRM, and BOIN Designs
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In early-phase clinical trials, determining the dose range and therapeutic window is critical. The purpose of the early-phase studies may ju...
1 comment:
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