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CLINICAL TRIAL PROTOCOL Title: A Phase 1b dosefinding study of DDFPe in acute ischemic stroke Protocol Number: NVX208AIS UAMS IRB Number: 205529 Phase: 1bStudy Principal Investigator:William Culp,
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What is a phase 1b dose-finding?
Phase 1b dose-finding is a stage in clinical trials focused on identifying the optimal dose of a drug that is safe and effective for further testing. It often follows initial phase 1 trials and may involve a small group of patients.
Who is required to file a phase 1b dose-finding?
Sponsors of clinical trials, such as pharmaceutical companies or research institutions, are required to file a phase 1b dose-finding study with regulatory authorities to ensure compliance with safety and efficacy standards.
How to fill out a phase 1b dose-finding?
To fill out a phase 1b dose-finding study, researchers must complete regulatory documents detailing the study design, objectives, patient population, dosage regimens, safety assessments, and data collection methods.
What is the purpose of a phase 1b dose-finding?
The purpose of a phase 1b dose-finding is to establish a safe and effective dosage for a new treatment, inform the design of subsequent trials, and assess the drug’s pharmacokinetics and pharmacodynamics.
What information must be reported on a phase 1b dose-finding?
Information that must be reported includes trial protocols, dosing regimens, patient demographics, safety data, adverse events, and preliminary efficacy results.
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