title: PQRI recommendations on particle-size analysis of drug substances used in oral dosage forms.
abstract: This document provides information for the Pharmaceutical Industry and the Federal Drug Administration (FDA) regarding the selection of suitable particle-size analysis techniques, development and validation of particle-size methods, and the establishment of acceptance criteria for the particle size of drug substances used in oral solid-dosage forms. The document is intended for analysts knowledgeable in the techniques necessary to conduct particle-size characterization (a table of acronyms is provided at the end of the document). It is acknowledged that each drug substance, formulation, and manufacturing process is unique and that multiple techniques and instruments are available to the analyst.
authors.affiliation: Eli Lilly & Company, Lilly Corporate Center, Indianapolis, Indiana 46285-0001, USA. snorek_sharon_m@lilly.com
authors.forename: Sharon M
authors.initials: SM
authors.lastname: Snorek
authors.forename: John F
authors.initials: JF
authors.lastname: Bauer
authors.forename: Nallaperumal
authors.initials: N
authors.lastname: Chidambaram
authors.forename: William H
authors.initials: WH
authors.lastname: Doub
authors.forename: Eric P
authors.initials: EP
authors.lastname: Duffy
authors.forename: Frank M
authors.initials: FM
authors.lastname: Etzler
authors.forename: Richard N
authors.initials: RN
authors.lastname: Kelly
authors.forename: Justin J
authors.initials: JJ
authors.lastname: Lane
authors.forename: Ronald L
authors.initials: RL
authors.lastname: Mueller
authors.forename: Hullahalli R
authors.initials: HR
authors.lastname: Prasanna
authors.forename: Chetan P
authors.initials: CP
authors.lastname: Pujara
authors.forename: Van D
authors.initials: VD
authors.lastname: Reif
authors.forename: Brian
authors.initials: B
authors.lastname: Scarlett
authors.forename: Joseph G
authors.initials: JG
authors.lastname: Stowell
authors.forename: Pascal H
authors.initials: PH
authors.lastname: Toma
mesh_terms: D000284:Administration, Oral; D016477:Artifacts; D004345:Drug Industry; D008853:Microscopy; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D012542:Scattering, Radiation; D013678:Technology, Pharmaceutical / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations