Results 81 to 90 of about 1,122,477 (316)
FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications
This paper describes a new FDA’s pharmaceutical quality assessment system: Knowledge-aided Assessment & Structured Application (KASA). The KASA system is designed to: 1) capture and manage knowledge during the lifecycle of a drug product; 2) establish ...
Lawrence X. Yu+5 more
doaj
Animal and Clinical Pharmacologic Techniques in Drug Evaluation [PDF]
John H. Nodine, PETER E. SIEGLEH
openalex +1 more source
This study highlights the importance of multi‐omic analyses in characterizing colorectal cancers. Indeed, our analysis revealed a rare CMS1 exhibiting dampened immune activation, including reduced PD‐1 expression, moderate CD8+ T‐cell infiltration, and suppressed JAK/STAT pathway.
Livia Concetti+10 more
wiley +1 more source
Regulatory considerations for paediatric drug evaluation in China. [PDF]
Geng Y+8 more
europepmc +1 more source
Dual targeting of AKT and mTOR using MK2206 and RAD001 reduces tumor burden in an intracardiac colon cancer circulating tumor cell xenotransplantation model. Analysis of AKT isoform‐specific knockdowns in CTC‐MCC‐41 reveals differentially regulated proteins and phospho‐proteins by liquid chromatography coupled mass spectrometry. Circulating tumor cells
Daniel J. Smit+19 more
wiley +1 more source
Advanced lung organoids and lung-on-a-chip for cancer research and drug evaluation: a review. [PDF]
Zhu L+9 more
europepmc +1 more source
Alectinib resistance in ALK+ NSCLC depends on treatment sequence and EML4‐ALK variants. Variant 1 exhibited off‐target resistance after first‐line treatment, while variant 3 and later lines favored on‐target mutations. Early resistance involved off‐target alterations, like MET and NF2, while on‐target mutations emerged with prolonged therapy.
Jie Hu+11 more
wiley +1 more source
Evaluation of Gastric Acid as a Factor in Drug-Induced Gastric Hemorrhage in the Rat
David A. Brodie, Barbara J. Chase
openalex +2 more sources
Several epidemiological studies have found an association between maternal antibiotics use during pregnancy and increased risk of certain cancer types, although conclusions differ between studies.
Xibiao Ye+3 more
doaj +1 more source
Value-Based Generic Drug Evaluation Focus on Chinese Real-World Evidence. [PDF]
Lu J, Ying X, Li Z.
europepmc +1 more source