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Progress in Medical Sciences ISSN: 2577 - 2996
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Progress in Medical Sciences. 2022; 6(5):(148-202)


A Technical Overview of the Pharmaceutical Development Process and Best Practices

Rohit Singhal

Abstract
The pharmaceutical development process is the foundation for the production of safe, effective, and highquality medications. This article explores the complex stages of pharmaceutical development, starting with the significance of selecting appropriate drug substances and excipients, formulation development, and establishing robust manufacturing processes. The integration of Quality by Design (QbD) principles and advanced risk management strategies is discussed as a means to optimize development and ensure regulatory compliance. By adhering to the guidelines outlined by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use considerations (ICH) guideline Q8 (R2) on pharmaceutical development, pharmaceutical companies can enhance product quality, reduce variability, and ensure the consistent delivery of therapeutic products to the market.