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Physical Attributes/Particle Size Working Group
(Chair) Sharon Snorek

The Physical Attributes/ Particle Size WG is discussing test methods and specification-setting for particles of active pharmaceutical ingredients in oral dosage forms.

ICH Q2A http://www.fda.gov/cder/guidance/ichq2a.pdf
ICH Q2B http://www.fda.gov/cder/guidance/1320fnl.pdf
ICH Q6A http://www.fda.gov/OHRMS/DOCKETS/98fr/122900d.pdf

Work Plan

Drug Substance Particle Size Work Plan (PDF)

Meeting Minutes

  • March 26, 2001 (PDF)
  • April 27, 2001 (PDF)
  • March 20, 2001
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