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1. S3A guidance: note for guidance on toxicokinetics : the assessment of systemic exposure in toxicity studies : focus on microsampling : questions and answers

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):
Blood Specimen Collection -- methods
Drug Evaluation, Preclinical -- methods
Pharmaceutical Preparations -- administration & dosage
Sample Size
Toxicity Tests -- methods
Toxicokinetics
Pharmacokinetics
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Consideration of uncertainty in making benefit-risk determinations in medical device premarket approvals, de novo classifications, and humanitarian device exemptions: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):
Compassionate Use Trials -- standards
Cost-Benefit Analysis
Device Approval -- standards
Equipment and Supplies -- classification
Uncertainty
Data Collection
Reagent Kits, Diagnostic
Research Design
Sample Size
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Federal survey sample size analysis: disability, language, and sexual orientation and gender identity

Author(s):
Hartman, Lacey, author
Turner, Karen, (Of State Health Access Data Assistance Center (Minn.)), author
Publication:
[Minneapolis, Minnesota] : State Health Access Data Assistance Center (SHADAC), Division of Health Policy and Management, University of Minnesota, School of Public Health, September 14, 2023
Subject(s):
Disabled Persons
Federal Government
Gender Identity
Language
Sample Size
Sexual Behavior
Surveys and Questionnaires
United States