Parag Kolhe • Mrinal Shah • Nitin Rathore
Editors

2013

Formulation, Process, Quality
and Regulatory Considerations

Sterile products represent a significant fraction of parenteral products and encompass a variety of challenging dosage forms. Development of sterile products poses multifaceted challenges which can be broadly categorized into three areas: formulation dosage form development, processing and manufacturing and assurance of purity, safety and efficacy of the manufactured product.