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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)

PDE5-001

IonSense, Inc.

Tom Phillips

Jerry

Zweigenbaum

PDE5-002

CAMAG

Katerina Mastovska

Roy Liton

PDE5-003

FDA

Phil Koerner

Fenhong Song;

John Spzylka

PDE5-004

Promega

Jerry Zweigenbaum

Teresa Cain

PDE5-005

Covance

Teresa Cain

Tom Phillips

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