Enhancing Pharmacokinetic Studies to Support Tier 2 Labeling Claims for Abuse Deterrent Opioids

Time

Wed, Jun 17 9:00AM
W 07

Title

Enhancing Pharmacokinetic Studies to Support Tier 2 Labeling Claims for Abuse Deterrent Opioids

Abstract Summary

ORAL PRESENTATION SCHEDULED: Wednesday, June 17 in Session #2A at 9:49 - 9:54 am in the Exhibit Hall Poster Area (Hall A entrance)

The guidances published by FDA and Health Canada on abuse deterrent or tamper resistant opioids were reviewed for studies required for label claims; the PK studies required to support Tier 2 claims and its relevance for human abuse potential studies (Tier 3 claims) design are identified.

Poster Presenter

Hiren Mehta
PhD,
INC Research
Canada