PPT Slide

PARTICLE SIZE DISTRIBUTION (PSD)

Team’s Commitment Made at OINDP Subcommittee Meeting:

• Examine the relevancy of the mass balance requirement as a product specification versus system suitability requirement.

• Investigate if fewer than 3-4 stage groupings can provide equivalent control.

Team’s Approach:

Collect worldwide database to investigate actual PSD capabilities and appropriate statistical approaches for control of PSD in OINDP

Question Investigated in the Initial Assessment:

• Can the current state of OINDP technology generally comply with the mass balance criterion in the draft FDA CMC Guidances?
  

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