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This document outlines the clinical protocol for a phase 2 study evaluating the effectiveness and safety of TRC105 in treating recurrent or progressive glioblastoma after prior antiangiogenic therapy.
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What is IND 100522?
IND 100522 is an investigational new drug application submitted to regulatory authorities to seek approval for a new drug's clinical trials.
Who is required to file IND 100522?
Pharmaceutical companies or sponsors who wish to conduct clinical trials of a new drug must file IND 100522.
How to fill out IND 100522?
To fill out IND 100522, sponsors must provide comprehensive information including the drug's chemistry, pharmacology, and toxicology data, as well as a protocol for the clinical trials.
What is the purpose of IND 100522?
The purpose of IND 100522 is to ensure the safety and efficacy of the new drug before it can be tested in humans, thus protecting trial participants.
What information must be reported on IND 100522?
IND 100522 must report information on the drug's composition, manufacturing process, preclinical study results, proposed clinical trial protocols, and investigator qualifications.
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