Results 91 to 100 of about 4,829,888 (359)
Molecular Oncology, EarlyView.Pre‐analytical handling critically determines liquid biopsy performance. This study defines practical best‐practice conditions for cell‐free DNA (cfDNA) and extracellular vesicle–derived DNA (evDNA), showing how processing time, storage conditions, tube type, and plasma input volume affect DNA integrity and mutation detection.
Jonas Dohmen +11 more
wiley +1 more source
The New FDA Real-World Evidence Program to Support Development of Drugs and Biologics
Journal of Diabetes Science and Technology, 2020 FDA has launched a Real World Evidence (RWE) Program for using real-world evidence (RWE) to help support new indications for already approved drugs or biologics and postapproval studies.
D. Klonoff
semanticscholar +1 more source
Interrogating the immune landscape of microsatellite stable RAS‐mutated colon cancer
Molecular Oncology, EarlyView.COLOSSUS project RAS‐mutated MSS colon cancer study explored transcriptomics and immune cell density by immunohistochemistry (IHC), Immunoscore (IS), ISIC/TuLIS scores, mutation counts, and detected different prevalences but similar microenvironment composition across immune markers with clinical relevance for future immunotherapy combination ...
Rodrigo Dienstmann +61 more
wiley +1 more source
Erythrocyte PIG‐A mutant frequencies in cancer patients receiving cisplatin
Cancer MedicineBackground Cisplatin is a primary chemotherapy choice for various solid tumors. DNA damage caused by cisplatin results in apoptosis of tumor cells. Cisplatin‐induced DNA damage, however, may also result in mutations in normal cells and the initiation of ...
Vasily N. Dobrovolsky +6 more
doaj +1 more source
A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims [PDF]
, 2007 This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why ...
Kessler, David A., Vladeck, David C.
core +1 more source
Molecular Dynamics Studies on HIV-1 Protease: Drug Resistance and Folding Pathways [PDF]
, 2001 Drug resistance to HIV-1 Protease involves accumulation of multiple mutations in the protein. Here we investigate the role of these mutations by using molecular dynamics simulations which exploit the influence of the native-state topology in the folding ...
Carloni, Paolo +3 more
core +2 more sources
Molecular Oncology, EarlyView.Cytarabine is a key therapy for acute myeloid leukaemia (AML), but its efficacy is limited by the dNTPase SAMHD1, which hydrolyses its active metabolite. Screening nucleotide biosynthesis inhibitors revealed that IMPDH inhibitors selectively sensitise SAMHD1‐proficient AML cells to cytarabine.
Miriam Yagüe‐Capilla +9 more
wiley +1 more source
Ethical Issues in the Drug Approval Process [PDF]
, 2013 The Food and Drug Administration’s (FDA) drug approval process carries great significance for both pharmaceutical companies and for patients. In recent decades, there has been a shift towards expedited approval so that drugs, especially those for ...
McInnis, Meghan
core +1 more source
Potential COVID-19 papain-like protease PLpro inhibitors: repurposing FDA-approved drugs
PeerJ, 2020 Using the crystal structure of SARS-CoV-2 papain-like protease (PLpro) as a template, we developed a pharmacophore model of functional centers of the PLpro inhibitor-binding pocket. With this model, we conducted data mining of the conformational database
V. Kouznetsova +4 more
semanticscholar +1 more source
Molecular Oncology, EarlyView.Targeted therapy was evaluated in SHH medulloblastoma using neuroepithelial stem cell (NES) and tumor‐derived NES‐like (tNES) models in 2D monolayers and 3D spheroids. PI3K, AKT, and CDK4/6 inhibitors had minimal effects in NES but markedly reduced viability and growth and induced apoptosis in tNES cells, revealing distinct therapeutic vulnerabilities.
Monika Lukoseviciute +4 more
wiley +1 more source