SPDS Set 1 ERP Book

MEMORANDUM

D ATE :

A UGUST 4, 2015

T O :

SPDS SET 1 E XPERT R EVIEW P ANEL M EMBERS (PDE5 I NHIBITORS )

F ROM :

AOAC INTERNATIONAL

S UBJECT : PDE5 I NHIBITOR M ETHOD S UBMISSIONS AND R EVIEWS ____________________________________________________________________________ BACKGROUND: Three methods were submitted in response to the PDE5 Inhibitors Calls for Methods. The reviews submitted are provided in this meeting book, and links to the Standard Method Performance Requirements SM (SMPRs) and the candidate methods themselves are provided below.

AOAC Candidate Method Number

Submitter

Primary Reviewer

Secondary Reviewer(s) Jerry Zweigenbaum

PDE5-001

IonSense, Inc.

Tom Phillips

PDE5-002 PDE5-003 PDE5-004 PDE5-005

CAMAG

Katerina Mastovska

Roy Liton

FDA

Phil Koerner

Fenhong Song; John Spzylka

Promega Covance

Jerry Zweigenbaum

Teresa Cain Tom Phillips

Teresa Cain

• AOAC SMPR 2014.010 - Identification of Phosphodiesterase Type 5 (PDE5) Inhibitors in Dietary Ingredients and Supplements • AOAC SMPR 2014.011 - Determination of Phosphodiesterase Type 5 (PDE5) Inhibitors in Dietary Ingredients and Supplements • AOAC SMPR 2014.012 - Screening Method for Phosphodiesterase Type 5 (PDE5) Inhibitors in Dietary Ingredients and Supplements