QUALITY BY DESIGN- A NEW APPROACH TO DRUG DEVELOPMENT
Journal Title: International Journal of Drug Regulatory Affairs - Year 2015, Vol 3, Issue 2
Abstract
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.
Authors and Affiliations
Dey Rumel, Chowdhury DR
Keywords
Related Articles
- EP ID EP339347
- DOI -
- Views 93
- Downloads 0
Comparative study of the harmonization of pharmaceutical regulations in the western and central sub-regions of Africa
The harmonization of pharmaceutical regulations in Africa aims to offer States a coherent body of texts and practices by combining limited resources. The objective of this study was to describe policies to harmonize phar...
Overview of current Regulations governing Medical Devices
Medical Device (MD) is one of the fastest growing sector and so are the associated regulations. From lack of even policies and guidelines to stringent MD legislations in others, the requirements vary across countries. Un...
REGULATIONS OF REGISTRATION AND IMPORT OF MEDICAL DEVICE IN INDIA
India is a huge market for medical devices and is increasing constantly for the last few years. The registration certificate and import license is mandatory for a manufacturer of India who wishes to import any medical de...
EMERGENCY USE AUTHORIZATION: AT ZERO HOUR
The Emergency Use Authorisation (EUA) authority plays a vital role in US FDA. They provide the authority/permission to use the unregistered products/registered product with unregistered route to treat the life threatenin...
REGULATORY PERSPECTIVES OF PHARMACEUTICAL PRODUCTS IN GHANA
Drug Registration is a procedure of expertise of pharmaceutical product quality, efficacy and safety by the Regulatory Authority. The emergence of various formats has enabled the manufacturers of the drug to easily gain...