№ files_lp_3_process_7_089186
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Bibliographic reference list compiling U.S. federal regulations, FDA guidance documents, and professional standards concerning donor eligibility and infectious disease risk mitigation for human cells, tissues, and cellular and tissue-based products.
Year:
2004–2018
Country:
United States
Subject:
Donor eligibility and screening requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps)
Document Type:
Reference list
Issuing Authority:
U.S. Department of Health and Human Services; Food and Drug Administration; Centers for Disease Control and Prevention; AABB; FACT/JACIE
Legal Framework:
21 CFR 1271, Subpart C – Donor Eligibility
Referenced Publications:
Final Rule (69 FR 29785, May 25, 2004); FDA Guidance for Industry documents (August 2007; November 2016; May 2017; May 2018); CDC Yellow Book; AABB Standards for Cellular Therapy Product Services; FACT/JACIE International Standards
Target Audience:
Industry stakeholders involved in donor screening and cellular therapy product services
Related Topics:
Zika virus; West Nile virus; Hepatitis B virus; human-derived clotting factor concentrates; malaria
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Year:
2004–2018
Region / City:
Kenya
Institutional Context:
Nairobi Securities Exchange
Subject:
Inventory management and financial performance
Document Type:
Academic research article
Research Design:
Descriptive research design
Methodology:
Panel regression model
Theoretical Framework:
Transaction cost economics theory
Data Source:
Annual audited financial statements
Sample Size:
42 non-financial firms
Hypothesis Test:
Hausman Test (p-value 0.05)
Key Variables:
Inventory management, financial performance, firm size
Population:
Non-financial firms listed at the Nairobi Securities Exchange
Keywords:
Current asset management, financial performance, firm size, non-financial firms
Year:
2010
Region / City:
Grahamstown
Subject:
Biomaterials transfer, research agreements
Document Type:
Agreement
Organization / Institution:
South African Institute for Aquatic Biodiversity (SAIAB)
Author:
SAIAB Collections Manager
Target Audience:
Researchers, research institutions
Effective Period:
Not specified
Approval Date:
18 March 2010
Modification Date:
Not specified
Context:
Legal agreement for the transfer of biomaterials from SAIAB collections to researchers for research purposes.
Year:
2009
Subject:
Biology
Topic:
Plant structure and function
Educational standard:
Next Generation Sunshine State Standards
Benchmark code:
SC.912.L.14.7
Course level:
Biology 1
Document type:
Student instructional packet
Institution:
Office of Academics and Transformation
Academic focus:
Plant organs, tissues, and physiological processes
Target audience:
Secondary school students
Content components:
Tutorial activities, background reading, vocabulary, questions, tables
Source attribution:
Department of Biology, University of Pennsylvania
Curricular context:
Organisms, populations, and ecosystems
Year:
2004
Region / City:
USA
Topic:
Health regulations, Donor eligibility
Document type:
Regulatory guidance
Organization / Institution:
U.S. Department of Health and Human Services, Food and Drug Administration
Author:
U.S. Department of Health and Human Services, Food and Drug Administration
Target audience:
Healthcare professionals, tissue product manufacturers
Period of validity:
N/A
Approval date:
May 25, 2004
Date of changes:
N/A
Context:
Regulatory guidelines and FDA documentation related to the eligibility criteria for donors of human cells, tissues, and cellular products.
Year:
2013
Region / City:
Australia
Subject:
Human cellular and tissue therapies (HCTs) regulation
Document Type:
Regulatory Impact Statement
Institution:
Therapeutic Goods Administration (TGA)
Author:
Office of Scientific Evaluation / Office of Manufacturing Quality
Target Audience:
Government, Healthcare professionals, Industry stakeholders
Effective Date:
January 2013
Period of Validity:
Ongoing revision of standards
Date of Approval:
January 2013
Date of Last Revision:
N/A
Year:
2019-2020
Region / City:
Shanghai, China
Field:
Medical research, oncology
Document type:
Research article
Institution:
Zhongshan Hospital Fudan University
Authors:
Not specified
Target audience:
Researchers, medical professionals
Study period:
May 2019 - February 2020
Approval date:
B2019-060R
Follow-up end date:
March 31, 2020
Year:
2017
Region / City:
Netherlands, Canada
Topic:
DNA Methylation Analysis
Document Type:
Research Supplementary Materials
Institution:
Not specified
Author:
Forest et al.
Target Audience:
Researchers in genomics and molecular biology
Period of validity:
Not specified
Date of approval:
Not specified
Date of changes:
Not specified
Note:
Year
Theme:
Plant biology
Document type:
Educational material
Target audience:
Students, researchers
Procedure Code:
CPT 51715
Procedure Name:
Endoscopic injection of implant material into the submucosal tissues of the urethra and/or bladder neck
Clinical Indication:
Stress urinary incontinence in women
Population:
Women with stress urinary incontinence
Evidence Sources:
Cochrane Review (Kirchin 2012); NICE 2005; NICE 2019; American Urology Association 2017; Syan 2016; MODA 2019; Aetna 2019
Study Types Referenced:
Randomized controlled trials; case series; systematic review; guideline statements
Comparators:
Conservative treatment; placebo injection; surgical management; pelvic floor muscle training
Reported Outcomes:
Continence rates; quality of life; patient satisfaction; adverse events; objective cure
Adverse Events Reported:
Urinary tract infection; urinary retention; dysuria; abscess; urgency of micturition; prolonged pain; haemorrhage; migration of bulking agent; allergic reaction
Regulatory Reference:
FDA-cleared bulking agents listed (Coaptite, Contigen, Durasphere, Macroplastique, Uryx)
Coverage Criteria:
Prior conservative management; defined duration of symptoms; documented improvement after initial treatments; limitation on number of injections
Guideline Recommendations:
Consider in patients unsuitable for or declining surgery; counseling on limited long-term efficacy and potential need for repeat injections
Review Date Mentioned:
August 2019
Title:
Million Match Teach-In 1: What Is Hyp? Connective Tissues and Care Access
Date:
December 9, 2024
Campaign Period:
December 2024 through May 2025
Organization:
Hyp+Access
Program:
Hyp+Care
Event Format:
Live virtual teach-in (Zoom) with asynchronous YouTube access
Type of Document:
Event transcript / educational presentation transcript
Speakers:
L Tuthall; Audre Wirtanen
Roles:
Directors of Hyp+Access
Topic:
Hyp; connective tissue variance; care access
Audience:
Community members, patients, families, practitioners
Accessibility Features:
Auto captions; visual descriptions; chat moderation; captioned recording; published sources
Website:
hypaccess.org
Launch Context:
Opening event of the Million Match campaign
Book Title:
Memmler’s Structure and Function of the Human Body
Edition:
11th Edition
Unit:
Unit I: The Body as a Whole
Chapter:
Chapter 4
Chapter Title:
Tissues, Glands, and Membranes
Page References:
pp. 64–75
Subject Area:
Human Anatomy and Physiology
Topics Covered:
Tissue origins; epithelial, connective, muscle, and nervous tissues; glands and secretions; membranes; tissue and aging
Document Type:
Chapter notes outline
Intended Audience:
Students of anatomy and physiology
Year:
2023
Organism:
Mus musculus
Tissue types:
Optic nerve, cerebellum, C2C12 cells
Techniques:
Cell lysis, transfection, RNA extraction, western blotting, immunofluorescence, RT-PCR
Reagents and tools:
RSB-100 buffer, TriZOL, Turbo DNase, Lipofectamine2000, plasmids (pcDNA3.1, tdTomato, Qk reporters), siRNAs, morpholinos, primary and secondary antibodies
Institution:
University of California, Santa Cruz
Animal model:
Adult wild-type 129-C57BL/6 mice
Ethics approval:
UCSC Institutional Animal Care and Use Committee
Target proteins:
QKI isoforms (QKI-5, QKI-6, QKI-7), GAPDH, Myc, HA, histone H3, tdTomato
Assays:
Dual Glo Luciferase Assay, BioAnalyzer quantitation, RT-qPCR
Method type:
Experimental protocol
Supplementary information:
Details on plasmid construction, antibody sources, and subcellular fractionation
Document Type:
Supplemental figure legends
Field:
Molecular biology
Research Area:
Gastrointestinal epithelium and intestinal metaplasia
Subjects:
CDX2, HNF4A, SOX2, gastric organoids, Barrett’s esophagus, gastric intestinal metaplasia
Biological Material:
Human gastrointestinal tissues and mouse stomach organoids
Methods:
Single-cell RNA-seq, bulk RNA-seq, ATAC-seq, CUT&RUN, ChIP-seq, GSEA, enhancer analysis, immunohistochemistry, qRT-PCR
Referenced Studies:
Busslinger et al. 2021b; Nowicki-Osuch et al. 2021; Owen et al. 2018; Companioni et al. 2017; Singh et al. 2021; Gao and Kaestner 2010; Wang et al. 2013
Key Topics:
Transcriptional profiling, chromatin accessibility, enhancer activity, transcription factor binding, intestinalization of gastric epithelium
Species:
Homo sapiens; Mus musculus
Pathological Context:
Barrett’s esophagus; gastric intestinal metaplasia
Document type:
Ethics self-assessment form
Subject area:
Research ethics
Context:
EU grant application process
Programme / initiative:
INNOVISION Postdoctoral COFUND
Responsible framework:
European Union research funding procedures
Primary topics:
Human embryonic stem cells, human embryos, human participants, human cells and tissues
Regulatory reference:
Clinical Trial Regulation 536/2014
Required documentation:
Ethics approvals, informed consent forms, information sheets, registry confirmations
Geographical scope:
European Union
Relevant registry:
European registry for human embryonic stem cell lines (hPSCreg)
Purpose within process:
Ethics compliance verification in research proposals
Year:
2026
Region / City:
Not specified
Topic:
Small Cell Lung Cancer, Gene Expression
Document Type:
Supplementary Figure / Research Data
Institution:
GTEx, Amgen
Methodology:
RNA-Seq, Immunohistochemistry, Flow Cytometry
Sample Size:
28 SCLC tumor samples, 3,789 GTEx normal tissue samples, 518 Amgen normal tissue samples
Markers:
DLL3
Data Visualization:
Log2 FPKM + 0.1, Photomicrographs
Experimental Details:
Secondary antibody controls included
Year:
2023
Region / City:
Not specified
Topic:
Oncology, Tumor Biomarkers
Document Type:
Research Supplementary Material
Institution:
Not specified
Author:
Not specified
Patient Cohort:
Bladder cancer patients
Sample Type:
Tumor tissues and organoids
Methodology:
Gene expression analysis using R software, Wilcoxon Rank Sum and Signed Rank Tests
Tumor Types:
GBM, GBMLGG, LGG, UCEC, BRCA, LUAD, ESCA, STES, KIRP, KIPAN, COAD, COADREAD, PRAD, STAD, HNSC, KIRC, LUSC, LIHC, WT, SKCM, BLCA, THCA, READ, OV, PAAD, TGCT, UCS, LAML, ACC, KICH, CHOL
Clinical Data Included:
Patient sex, age, pathological classification, prior therapy, organoid culture status
Figures:
Supplementary Figures S1, S2
Tables:
Supplementary Table 1