Subjects: 3 selected / Genre: Guideline and Technical Report / Copyright: Public domain / Dates by Range: 2000 and later - Digital Collections - National Library of Medicine Search Results

Start Over Subjects United States. Food and Drug Administration. ✖ Subjects Investigational New Drug Application ✖ Subjects Research Design ✖ Genre Guideline ✖ Genre Technical Report ✖ Copyright Public domain ✖ Dates by Range 2000 and later ✖

1. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):: Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Physiologically based pharmacokinetic analyses--format and content

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Drug Evaluation, Preclinical
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Research Design
Software
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.