This manuscript presents an outline for a structured qualitative benefit-risk assessment process that sponsors can apply at the time of go/no-go decisions for phase III testing of pharmaceutical products. This approach takes into account the therapeutic and comparator context as well as product-...
The article offers information on the analysis regarding the eagerness of pharmaceutical companies and their shareholders to reach phase 3 clinical trials, in which the candidate drugs are tested for their effectiveness in the U.S.doi:10.1038/nm0412-477bPalmer...
Pabinafusp alfa (JR-141) is a novel enzyme drug that crosses the blood-brain barrier by transcytosis via transferrin receptors. In order to establish its efficacy and safety, a multicenter, single-arm, open-label phase 2/3 clinical trial was conducted in 28 Japanese patients with mucopoly...
"In addition,pharmaceutical companieswill be keen to invest in in-vitro diagnostics such as biomarkers; molecular, tissue, companion diagnostics; predisposition disease; and predictive testing," said Frost & Sullivan Life SciencesGlobal Program DirectorJennifer Lazar. "This is because drugs with companion...
[1.05–1.14] < 0.001 Abbreviation: uOR unadjusted Odds Ratio, aOR adjusted Odds Ratio, CI confidence interval, IQR interquartile range, FDA Food and Drug Administration a The most common primary endpoints used in phase 3 clinical trials other than overall survival and quality of life metrics ...
This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Changes in Clinicia...
To our knowledge, SPI-1005 is the only neurotologic drug currently in Phase 3 testing in the US, Europe, or Asia, that has demonstrated clinically relevant improvements in sensorineural hearing loss and tinnitus. About Sound ...
[Fam-] trastuzumab deruxtecan (T-DXd; formerly DS-8201a) is an antibody-drug conjugate with a humanized HER2 antibody, peptide-based cleavable linker, and a topoisomerase I inhibitor payload. It has a drug-to-antibody ratio of ~8 and the membrane permeability of the cleaved payload enables...
or more of the high risk features including t(4;14), t(14;16), or chromosome 17 deletion abnormalities. Individual site FISH testing and reports will be further reviewed as part of data assessment in the present study to confirm details, including cell numbers and percentages as well as ...
1.FDA guidance on the “Preparation of Investigational New Drug Products (Human and Animal)” 1991 (reprinted November 1992). 2.FDA “Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies.” 3.FDA “Gui...