Abstract

QUALITY BY DESIGN APPROACHES TO ANALYTICAL METHOD DEVELOPMENT: A MINI REVIEW

Shingne Snehal S.*, Bhujbal Akshay E., Bulbule Laxman D.***, Proff. Santosh Waghmare and Dr. H. V. kamble

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Abstract

(QBD) Quality by design is a systematic approach to and drug development. Predefined product specifications are done by, planning, developing, manufacturing respectively. Science risk-based management approaches are used for a predefined product. Analytical development method based on the same principle of QBD known as AQBD. The Traditional approach and analytical approach are specified in QBD. Analytical profile, risk Assessment, different critical quality attributes are used for various analytical techniques. Method validation and control strategy is put in place. Design space for the development of a product is required according to ICH Q8 guideline i.e. method operational design region. Analytical techniques are streamlined pathways for new drug development. Gives a new effective and unique approach.

Keywords: Quality, Analytical QBD, CQA, MODR.