Microsoft Word - SPDS_0918_ERP-Proposal-07-11-2018DMC

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Paula Brown  Canada  Statement of Expertise  I have published 18 validation studies including 3 collaborative studies and  4 OMAs. Sr. Staff Review  Dr. Brown has tremendous expertise in method development and  BCIT  Research  Academia 

validation.  She is a method author for two Echinacea method validations  and for ginseng. She has also served as chair of the SPDS Ginseng Working  Group to develop SMPRs. She has also served on initial AOAC ERP to  develop methods for echinacea.   She has only applied for the SPDS Echinacea ERP. 

Staff Recommendation  Recommend for the SPDS Echinacea ERP 

Anton Bzhelyansky 

USP 

Product  Certification 

NGO 

USA 

Statement of Expertise  Over the last 5.5 years I have been maintaining 150+ USP botanical monographs, including the several  identified above; developing new monographs and participating in numerous AOAC Working Groups  (chaired the Ginger WG) and ERPs.  My prior work included hands‐on development of analytical  methods for dietary ingredients and finished dosage forms; both botanical and non‐botanical.  Sr. Staff Review  Mr. Bzhelyansky has been very active within SPDS.  In addition to participating in numerous SPDS  working groups, he served as chair of the SPDS Ginger Working Group.  As there is no direct mention  of echinacea, he is very experienced with methods for dietary supplements.   He has only applied for the following SPDS ERP: Echinacea, Ginseng, and Kavalactones.  Staff Recommendation  Recommend for the SPDS Echinacea ERP  Recommend for the SPDS Ginseng ERP  Recommend for the SPDS Kavalactones ERP  Statement of Expertise  Throughout my educational and professional career, I have obtained extensive experience in the  development, optimization and validation of analytical methods for botanicals, natural products and  dietary supplements. I have performed and supervised single laboratory and collaborative validation  studies analytical methods including methods for the analysis of Aloe Vera, Ginseng, Echinacea,  Cranberry, Goldenseal, Turmeric and Kombucha, with several of the methods I have worked on being  published and accepted as first action OMA by AOAC. With my strong background and experience in  analytical chemistry and statistics I have a thorough understanding of the requirements to review and  evaluate method performance characteristics. Additionally, my pharmacognosy training has given a  solid foundation in natural products chemistry and the issues associated with analysis of complex  Michael Chan  BCIT  Research  Academia  Canada 

sample matrixes.  Sr. Staff Review