Laboratory-based testing to evaluate abuse-deterrent formulations and satisfy the Food and Drug Administration's recommendation for Category 1 Testing
| Autor: | Christopher Altomare, Edward J. Cone, August R. Buchhalter, Eric R. Kinzler, Anthony Costantino |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Quality Control
Prescription drug Chemistry Pharmaceutical Drug Compounding Advisory committee MEDLINE Abuse-Deterrent Formulations Abuse deterrent 030226 pharmacology & pharmacy Food and drug administration 03 medical and health sciences 0302 clinical medicine Medication abuse Humans Medicine Pharmacology (medical) Medical prescription Drug Approval Prescription Drug Misuse United States Food and Drug Administration business.industry General Medicine Opioid-Related Disorders medicine.disease United States Analgesics Opioid Substance abuse Anesthesiology and Pain Medicine Medical emergency business 030217 neurology & neurosurgery |
| Zdroj: | Journal of Opioid Management. 13:441-448 |
| ISSN: | 1551-7489 |
| DOI: | 10.5055/jom.2017.0420 |
| Popis: | The US Food and Drug Administration (FDA) considers the development of abuse-deterrent formulations of solid oral dosage forms a public health priority and has outlined a series of premarket studies that should be performed prior to submitting an application to the Agency. Category 1 studies are performed to characterize whether the abuse-deterrent properties of a new formulation can be easily defeated. Study protocols are designed to evaluate common abuse patterns of prescription medications as well as more advanced methods that have been reported on drug abuse websites and forums. Because FDA believes Category 1 testing should fully characterize the abuse-deterrent characteristics of an investigational formulation, Category 1 testing is time consuming and requires specialized laboratory resources as well as advanced knowledge of prescription medication abuse. Recent Advisory Committee meetings at FDA have shown that Category 1 tests play a critical role in FDA's evaluation of an investigational formulation. In this article, we will provide a general overview of the methods of manipulation and routes of administration commonly utilized by prescription drug abusers, how those methods and routes are evaluated in a laboratory setting, and discuss data intake, analysis, and reporting to satisfy FDA's Category 1 testing requirements. |
| Databáze: | OpenAIRE |
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