All terms in BMONT

Label Id Description
Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff BMONT_0000032 [The guidance representing the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current thinking on implementation of section 507 of the FD&C Act with respect to describing the process for requestors5 interested in qualifying DDTs and on taxonomy for biomarkers and other DDTs.]
estrogen receptor PR_000007204 [A protein that is a translation product of the human ESR1 gene or a 1:1 ortholog thereof.]
21st Century Cures Act BMONT_0000033 [The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.]
Pharmacogenetic Tests and Genetic Tests for Heritable Markers Guidance for Industry and FDA Staff BMONT_0000034 [The guidance document is intended to facilitate progress in the field of pharmacogenomics and genetics by helping to shorten development and review timelines, facilitate rapid transfer of new technology from the research bench to the clinical diagnostic laboratory, and encourage informed use of pharmacogenomic and genetic diagnostic devices. It provides recommendations to sponsors and FDA reviewers in preparing and reviewing premarket approval applications (PMA) and premarket notification (510(k)) submissions for pharmacogenetic and other human genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests). Array-based tests (commonly referred to as microarrays) are a subset of multiplex tests and are included in the scope of this document. The recommendations within this guidance for elements of a genetic test submission apply to pharmacogenetic (e.g., drug-metabolizing enzyme allele tests, single nucleotide polymorphism (SNP) analysis) and other types of genetic tests. Tests of gene expression and tests for non-heritable (somatic) mutations are not specifically addressed, although many of the same principles may apply. In addition, this guidance considers nucleic acid-based analysis only, but the principles may be applied to other matrices (e.g., protein) when the purpose is to provide genetic information.]
qualified biomarker BMONT_0000035 [Qualified biomarkers have the potential to provide valuable information that may reduce uncertainty in regulatory decisions during drug development. When a biomarker is qualified, it means that it has undergone a formal regulatory process to ensure that we can rely on it to have a specific interpretation and application in medical product development and regulatory review, within the stated context of use (COU) . It is important to note that a biomarker is qualified, and not the biomarker measurement method.]
total kidney volume BMONT_0000036 [Total Kidney Volume (TKV) is the primary measure of kidney growth and can provide information on disease status and its progression. MRI or CT scan are the best methods to obtain TKV measurements.]
urine total potein BMONT_0000038 [Urinary total protein (UTP) includes all proteins in urine samples. The presence of some quantities of proteins (<150 mg/day) is considered normal.]
gastric cancer MONDO_0001056 [A primary or metastatic malignant neoplasm involving the stomach.]
MAFG OMIT_0033345
generically dependent continuant BFO_0000031 [b is a generically dependent continuant = Def. b is a continuant that g-depends_on one or more other entities. (axiom label in BFO2 Reference: [074-001])]
survival time EFO_0000714 [Time of survival is an information entity which is about the length of time a material entity has survived after some adverse event, such as infection from a disease.]
neutrophil CL_0000775 [Any of the immature or mature forms of a granular leukocyte that in its mature form has a nucleus with three to five lobes connected by slender threads of chromatin, and cytoplasm containing fine inconspicuous granules and stainable by neutral dyes.]
granulocyte CL_0000094 [A leukocyte with abundant granules in the cytoplasm.]
process boundary BFO_0000035 [p is a process boundary =Def. p is a temporal part of a process & p has no proper temporal parts. (axiom label in BFO2 Reference: [084-001])]
MAF OMIT_0033342
X-Ray Imaging NCIT_C38101 [A radiographic procedure using the emission of x-rays to form an image of the structure penetrated by the radiation.]
function BFO_0000034
anatomical structure UBERON_0000061 [Material anatomical entity that is a single connected structure with inherent 3D shape generated by coordinated expression of the organism's own genome.]
clinical specificity BMONT_0000021 [Specificity of the biomarker, referred to as the ability of a biomarker or a change in biomarker to distinguish patients who are responders to an intervention from those who are non-responders in terms of changes in clinical endpoints.]
leptin PR_000009758 [A protein that is a translation product of the human LEP gene or a 1:1 ortholog thereof.]