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Jumat, 25 Maret 2016

Drug Development for Solid Oral Dosage

*These Following steps were taken from Pharmaceutical Online Newsletter based on US and Canada.

R&D

  • Formulation Development
  • Peocess Development
  • Development Batches

ANALYTICS

  • Preformulation
  • Drug Characterization
  • Method Development and Transfer
  • Analytical Release Testing and Stability Testing

CLINICAL

  • Scale-Up
  • Comparator Clinding
  • Clinical Supplies Management

MANUFACTURING

  • Blending
  • Top Spray Granulation
  • Wurster Coating
  • Encapsulation
  • Tablet Compression
  • High Shear Wet Granulation
  • Tablet Coating
  • Over Encapsulation

PACKAGING

  • Bottling
  • Flip-top Vial
  • Blister
  • Stick-pack
  • Sachet
  • Secondary Packaging for Solid Oral Dosage

DISTRIBUTION

  • Clinical Study Distribution
  • Collection
  • Destruction
  • Warehouse Depots