title: Advancing Product Quality: a Summary of the Second FDA/PQRI Conference.
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA. lawrence.yu@fda.hhs.gov.
authors: Lawrence X
authors: LX
authors: Yu
authors: Boehringer Ingelheim, Ridgefield, CT, 06877, USA.
authors: Ilgaz
authors: I
authors: Akseli
authors: Eli Lilly and Company, Indianapolis, IN, 46225, USA.
authors: Barbara
authors: B
authors: Allen
authors: University of Michigan, Ann Arbor, MI, 48109, USA.
authors: Gregory
authors: G
authors: Amidon
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Tara Gooen
authors: TG
authors: Bizjak
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Ashley
authors: A
authors: Boam
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Margaret
authors: M
authors: Caulk
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: David
authors: D
authors: Doleski
authors: Genentech/Roche, 1 DNA Way, South San Francisco, CA, 94080, USA.
authors: Joseph
authors: J
authors: Famulare
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Adam C
authors: AC
authors: Fisher
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Scott
authors: S
authors: Furness
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Brian
authors: B
authors: Hasselbalch
authors: Havel Biopharma LLC/Nanomedicines Alliance, Indianapolis, IN, 46220, USA.
authors: Henry
authors: H
authors: Havel
authors: University of Maryland, Baltimore, MD, 21201, USA.
authors: Stephen W
authors: SW
authors: Hoag
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Robert
authors: R
authors: Iser
authors: Perrigo Company plc, Allegan, MI, 49010, USA.
authors: Bruce D
authors: BD
authors: Johnson
authors: Abbvie, North Chicago, IL, 60064, USA.
authors: Robert
authors: R
authors: Ju
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Paula
authors: P
authors: Katz
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Emanuela
authors: E
authors: Lacana
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Sau L
authors: SL
authors: Lee
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Richard
authors: R
authors: Lostritto
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Grace
authors: G
authors: McNally
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Mehul
authors: M
authors: Mehta
authors: Merck and Company, Inc., West Point, PA, 19486, USA.
authors: Ganapathy
authors: G
authors: Mohan
authors: GlaxoSmithKline, Washington, DC, 20001, USA.
authors: Moheb
authors: M
authors: Nasr
authors: Pfizer, Inc, Eastern Point Road, Groton, CT, 06340, USA.
authors: Roger
authors: R
authors: Nosal
authors: Pfizer, Inc, Eastern Point Road, Groton, CT, 06340, USA.
authors: Mary
authors: M
authors: Oates
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Thomas
authors: T
authors: O'Connor
authors: University of Maryland, Baltimore, MD, 21201, USA.
authors: Jim
authors: J
authors: Polli
authors: Light Pharma Inc., Cambridge, MA, 02142, USA.
authors: G K
authors: GK
authors: Raju
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Mahesh
authors: M
authors: Ramanadham
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Giuseppe
authors: G
authors: Randazzo
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Susan
authors: S
authors: Rosencrance
authors: University of Michigan, Ann Arbor, MI, 48109, USA.
authors: Anna
authors: A
authors: Schwendeman
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Arzu
authors: A
authors: Selen
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Paul
authors: P
authors: Seo
authors: PQRI, Arlington, VA, USA.
authors: Vinod
authors: V
authors: Shah
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Ramesh
authors: R
authors: Sood
authors: Merck and Company, Inc., West Point, PA, 19486, USA.
authors: Michael P
authors: MP
authors: Thien
authors: Teva Pharmaceuticals USA, 223 Quaker Rd, Pomona, NY, 10970, USA.
authors: Tony
authors: T
authors: Tong
authors: Massachusetts Institute of Technology, Cambridge, MA, 02139, USA.
authors: Bernhardt L
authors: BL
authors: Trout
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Katherine
authors: K
authors: Tyner
authors: Teva Pharmaceuticals USA, 425 Privet Road, Horsham, PA, 19044, USA.
authors: Siva
authors: S
authors: Vaithiyalingam
authors: Amgen, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
authors: Martin
authors: M
authors: VanTrieste
authors: Eli Lilly and Company, Indianapolis, IN, 46225, USA.
authors: Fionnuala
authors: F
authors: Walsh
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Russell
authors: R
authors: Wesdyk
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Janet
authors: J
authors: Woodcock
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Geoffrey
authors: G
authors: Wu
authors: Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA.
authors: Larisa
authors: L
authors: Wu
authors: Abbvie, North Chicago, IL, 60064, USA.
authors: Louis
authors: L
authors: Yu
authors: Novartis, East Hanover, NJ, 07936, USA.
authors: Diane
authors: D
authors: Zezza
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000592:standards* / Q000639:trends; D003226:Congresses as Topic / Q000592:standards* / Q000639:trends; D004345:Drug Industry / Q000592:standards* / Q000639:trends; D006801:Humans; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards* / Q000639:trends