Microsoft Word - Candidates for 2018 ERP of the Year

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III.

PDE5 Inhibitors– August 4, 2015

PDE5 Inhibitors ERP Members Present: Brian Schaneberg, Starbucks (Chair); Phil Koerner, Phenomenex; Katerina Mastovska, Covance; Tom Phillips, State of MD; Fenhong Song, FDA; John Spzylka, Mérieux NutriSciences; Darryl Sullivan, Covance.

PDE5 Inhibitors ERP Members Absent: Teresa Cain, FDA; Liton Roy, Sancilio; Jerry Zweigenbaum, Agilent.

AOAC Method #

Manuscript Title

ERP Decisions

Consensus

Reviewers

PDE5-001

Title: Screening Method for Phosphodiesterase Type 5 (PDER5) Inhibitors in Dietary Ingredients and Supplements using High Resolution Mass Spectrometry

Motion 1: MOTION to not move PDE5-001 to First Action Official Methods SM status. Motion 2: ERP finds this method intriguing and would like to see a further submission of data demonstrating applicability towards the SMPR 2014.012. Motion 1: MOTION to not move PDE5-002 to First Action Official Methods SM status. Motion 2: MOTION that the ERP finds this method valuable for screening and would like to see a further submission of data demonstrating applicability towards the SMPR 2014.012. Motion 1: MOTION to not move PDE5-003 to First Action Official Methods SM status. Motion 2: MOTION that this method should: 1. Supply single lab validation data related to LOD. 2. Supply LIB data if available, and any other

Motion 1: Phillips/Sullivan, 6/0/1 (Abstain: Covance) Motion 2: Phillips/Sullivan, 6/0/1 (Abstain: Covance)

Primary: Tom Phillips Secondary: Not Submitted

Submitter: Brian Musselman, IonSense

PDE5-002

Title: Screening Method for Phosphodiesterase Type 5 (PDE5) Inhibitors in Dietary Ingredients and Supplements

Motion 1: Mastovska/Koerner, 6/0/1 (Abstain: Covance) Motion 2: Mastovska/Spzylka, 6/0/1 (Abstain: Covance)

Primary: Katerina Mastovska Secondary: Not submitted

Submitter: Tien Do, Camag

PDE5-003

Title: Adaption of the LC-MS Screen for PDE5 Inhibitors to UHPLC-MS

Motion 1: Koerner/Phillips, 5/0/2 (Abstain: Covance, Song)

Primary: Phillip Koerner

Submitter: Elisa Nickum, FDA

Secondary: John Spzylka

Motion 2: Koerner/Spzylka, 6/0/1 (Abstain:

03/12/2018