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Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose the subjects to unnecessary risks. Other commitments are commitments to obtain informed consent from the research subjects, to obtain a review of the study by an institutional review board (IRB), and to adhere to the investigational new drug ...
ICH E3: Structure and content of clinical study reports [24] aims to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. Read together with questions and answers. FDA: Safety Reporting Requirements for INDs and BA/BE Studies. [25]
Phase II clinical programs historically have experienced the lowest success rate of the four development phases. In 2010, the percentage of Phase II trials that proceeded to Phase III was 18%, [16] and only 31% of developmental candidates advanced from Phase II to Phase III in a study of trials over 2006–2015. [17]
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
Precision is also developing PBCAR19B as an anti-CD19 [26] stealth cell candidate that employs a single gene edit to knock down beta-2 microglobulin, for which a Phase 1 study began in June 2021. [ 27 ] [ 28 ] The company is also conducting a Phase 1/2a clinical trial evaluating PBCAR269A, its investigational allogeneic B-cell maturation ...
A phase I study investigated the maximum tolerated dose of Custirsen in patients with recurrent or refractory high-grade gliomas. [ 8 ] The recommended and safe dosing of Custirsen was determined in a Phase I same-dose escalation scheme involving forty patients with tumours known to upregulate clusterin with metastatic or locally recurrent ...
The chemical name of BIA-10-2474 is 3-(1-(cyclohexyl(methyl)carbamoyl)-1H-imidazol-4-yl)pyridine 1-oxide. [8] BIA-10-2474 is a long-acting inhibitor of fatty acid amide hydrolase (FAAH) that increases levels of the neurotransmitter anandamide in the central nervous system and in peripheral tissues (that is, the rest of the body other than the brain and spinal cord).
Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of a Subcutaneously- and Orally- Administered Supplemental Spike & Nucleocapsid-targeted COVID-19 Vaccine to Enhance T Cell Based Immunogenicity in Participants Who Have Already Received Prime + Boost Vaccines Authorized For Emergency Use.