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543. Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug products containing high solubility drug substances

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):
Chemistry, Pharmaceutical
Drug Liberation
Solubility
Dosage Forms
Therapeutic Index, Drug
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

544. Quality attribute considerations for chewable tablets

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):
Chemistry, Pharmaceutical
Drug Liberation
Mastication
Quality Control
Solubility
Tablets -- pharmacokinetics
Drug Approval
Drug Labeling
Hardness
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

545. Microdose radiopharmaceutical diagnostic drugs: nonclinical study recommendations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):
Drug Evaluation, Preclinical
Radiopharmaceuticals -- administration & dosage
Radiopharmaceuticals -- pharmacokinetics
Diagnostic Imaging
Diagnostic Uses of Chemicals
Radiopharmaceuticals -- toxicity
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

547. Allergic rhinitis: developing drug products for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
Subject(s):
Clinical Trials as Topic
Drug Evaluation
Rhinitis, Allergic -- drug therapy
Adrenal Cortex Hormones -- therapeutic use
Adult
Child
Drug Combinations
Research Design
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

549. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):
Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

550. How would state-based individual mandates affect health insurance coverage and premium costs?

Author(s):
Blumberg, Linda J., author
Buettgens, Matthew, author
Holahan, John, author
Publication:
[New York, N.Y.] : Commonwealth Fund, July 2018
Subject(s):
Health Insurance Exchanges -- economics
Health Insurance Exchanges -- statistics & numerical data
Insurance Coverage -- economics
Insurance Coverage -- statistics & numerical data
Insurance, Health -- economics
Insurance, Health -- statistics & numerical data
Mandatory Programs -- economics
Medically Uninsured -- statistics & numerical data
State Government
Forecasting
Health Benefit Plans, Employee -- statistics & numerical data
Health Expenditures -- statistics & numerical data
Insurance Coverage -- trends
Insurance, Health -- trends
Medicaid -- statistics & numerical data
Models, Theoretical
Taxes
Uncompensated Care -- statistics & numerical data
Humans
United States
United States.
State Children's Health Insurance Program (U.S.)