Subjects: Administration, Oral and Investigational New Drug Application / Languages: English / Genre: Technical Report - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Administration, Oral ✖ Subjects Investigational New Drug Application ✖ Languages English ✖ Genre Technical Report ✖

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. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):: Biological Availability
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Therapeutic Equivalency
Administration, Oral
Biopharmaceutics -- classification
Drugs, Investigational -- administration & dosage
Excipients
Permeability
Prodrugs
Solubility
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.