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July 25, 2025Research Journal of Pharmaceutical Dosage Forms and Technology

Quality by Design (QBD) in Pharmaceutical Development: A Review of Principles and Case Studies

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Authors

LVLucky B. VasaveMaharashtra University of Health SciencesMBMayur BhamareJSS Academy of Higher Education and ResearchRBRushikesh L. BachhavMaharashtra University of Health Sciences

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Overview

This review highlights principles of quality by design in pharmaceutical development, showing its impact on product quality and risk management.

Key Points

  • Quality by design aims to incorporate quality into the design process, ensuring reliable production outcomes.
  • The key features of quality by design include defined quality attributes and well-managed process parameters.
  • ICH guidelines form the foundation of quality by design, emphasizing risk management and quality systems.
  • Implementing quality by design can improve pharmaceutical product development and overall product reliability.

Cite This Study

Vasave et al. (2025) studied this question.

synapsesocial.com/papers/68af59ddad7bf08b1eadeabdhttps://doi.org/10.52711/0975-4377.2025.00029
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Pharmaceutical Product Development: Quality by Design (QbD)2024 · 1 citations
  2. 2Quality by Design: An Over View in Pharma Industry2024 · 2 citations
  3. 3A REVIEW ON QUALITY BY DESIGN2026
  4. 4ANALYTICAL QUALITY BY DESIGN (AQBD) APPROACH FOR LIFECYCLE MANAGEMENT OF PHARMACEUTICAL ANALYTICAL METHODS2026
  5. 5QUALITY BY DESIGN (QBD) IN ANALYTICAL METHOD DEVELOPMENT: A SYSTEMATIC REVIEW OF PRINCIPLES, TOOLS AND REGULATORY PERSPECTIVES2026