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Start Over Subjects Biomarkers ✖Remove constraint Subjects: Biomarkers Publication Year 2000 to 2024 ✖Remove constraint Publication Year: <span class="from" data-blrl-begin="2000">2000</span> to <span class="to" data-blrl-end="2024">2024</span>

1. Bioanalytical method validation

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
Biomarkers
Documentation
Dried Blood Spot Testing -- standards
Investigational New Drug Application
Quality Control
Reagent Kits, Diagnostic -- standards
Sensitivity and Specificity
Specimen Handling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Diagnostic tests for Alzheimer's disease: generating and evaluating evidence to inform insurance coverage policy

Author(s):
Pearson, Steven D., author
Ollendorf, Daniel A., author
Colby, Jennifer A., author
Publication:
[Boston, MA] : Institute for Clinical and Economic Review, [2012]
Subject(s):
Alzheimer Disease -- diagnosis
Diagnostic Tests, Routine -- methods
Evidence-Based Practice
Insurance Coverage
Biomarkers
Biomedical Research -- methods
Clinical Protocols
Clinical Trials as Topic -- methods
Early Diagnosis
Insurance, Health
Neuropsychological Tests
Outcome Assessment (Health Care)
Patient Outcome Assessment
Policy Making
Practice Guidelines as Topic
Predictive Value of Tests
Prognosis
Randomized Controlled Trials as Topic
Reproducibility of Results
Translational Medical Research -- methods
Humans
United States

3. Hematologic malignancies: regulatory considerations for use of minimal residual disease in development of drug and biological products for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):
Biomarkers
Clinical Trials as Topic
Drug Approval
Drug Development
Drugs, Investigational
Hematologic Neoplasms -- drug therapy
Investigational New Drug Application
Neoplasm, Residual
Endpoint Determination
Leukemia, Lymphocytic, Chronic, B-Cell -- drug therapy
Leukemia, Myelogenous, Chronic, BCR-ABL Positive -- drug therapy
Leukemia, Myeloid, Acute -- drug therapy
Leukemia, Promyelocytic, Acute -- drug therapy
Multiple Myeloma -- drug therapy
Patient Selection
Precursor Cell Lymphoblastic Leukemia-Lymphoma -- drug therapy
Prognosis
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.