Standardization of In Vitro Testing During Development of Abuse‐Deterrent Opioids: Highlights From the Second and Third Category 1 Focus Group Meetings-Reference-Cited by-同舟云学术

Standardization of In Vitro Testing During Development of Abuse‐Deterrent Opioids: Highlights From the Second and Third Category 1 Focus Group Meetings

Published:2019-07 Issue:6 Volume:19 Page:580-585
ISSN:1530-7085
Container-title:Pain Practice
language:en
Short-container-title:Pain Pract

Author:

Elhauge Torben¹,Schwier Sebastian²,Hoag Stephen W.³,Setnik Beatrice⁴⁵,Bianchi Robert⁶,Altomare Christopher⁷,Toren Penny⁸,Lindhardt Karsten¹

Affiliation:

1. Egalet US Inc Wayne Pennsylvania U.S.A

2. Grünenthal GmbH Aachen Germany

3. Baltimore School of Pharmacy University of Maryland Baltimore Maryland U.S.A

4. Syneos Health Raleigh North Carolina U.S.A

5. Department of Toxicology and Pharmacology University of Toronto Toronto Ontario Canada

6. Prescription Drug Research Center Bradenton Florida U.S.A

7. DrugScan HorshamPennsylvania U.S.A

8. Vallon Pharmaceuticals, Inc Philadelphia Pennsylvania U.S.A

Funder

Category 1 Focus Group meeting

Publisher

Wiley

Subject

Anesthesiology and Pain Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/papr.12778

Reference11 articles.

1. Prescription Opioid Use, Misuse, and Use Disorders in U.S. Adults: 2015 National Survey on Drug Use and Health

2. Centers for Disease Control and Prevention.Understanding the epidemic.https://www.cdc.gov/drugoverdose/epidemic/index.html(accessed January 15 2019).

3. Medical outcomes associated with prescription opioid abuse via oral and non-oral routes of administration

4. The ALERRT® instrument: a quantitative measure of the effort required to compromise prescription opioid abuse-deterrent tablets

5. U.S. Food and Drug Administration.Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. U.S. Department of Health and Human Services.https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM492172.pdf(accessed January 11 2019).