Open AccessQUALITY BY DESIGN- A NEW APPROACH TO DRUG DEVELOPMENT
Author(s) -
Rumel Dey,
Debajyoti Roy Chowdhury
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v3i2.163
Subject(s) - quality by design , flexibility (engineering) , risk analysis (engineering) , quality (philosophy) , pharmaceutical industry , drug development , process management , new product development , business , drug , product (mathematics) , product lifecycle , computer science , management science , engineering , marketing , medicine , pharmacology , management , economics , philosophy , epistemology , geometry , mathematics
Quality by design is an essential part of the modern approach to pharmaceutical quality. A new approach to drug development could increase efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product’s life cycle. QbD has become the answer to assist both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to pharmaceutical development.