Abstract Background Quality by Design (QbD) is a pharmaceutical quality management
system that predicts, controls, and systematically responds to risks that may occur in the …

Regulatory science for generic dry powder inhalation products worldwide has evolved over
the last decade. The revised draft guidance Metered Dose Inhaler (MDI) and Dry Powder …

This research attempts to bring together the positive aspects of lipid nanoparticles and
Quality by Design (QbD) approach for developing a novel drug delivery system for skin …

Abstract With Quality by Design (QbD), a systematic approach involving design and
development of all production processes to achieve the final product with a predetermined …

Fruit extracts of Momordica charantia L.(Cucurbitaceae) and Abelmoschus esculentus (L.)
Moench (Malvaceae) have shown promising antidiabetic activities in clinical trials. However …

Abstract Design and formulation of an ideal pharmaceutical product is a tedious job for a
formulator as it comprises multiple objectives. The traditional method followed for years is …

In drug, medical, and consumer products businesses, leaders should establish strategies
that ensure production of quality products and drive profitability. Sales of defective or …

The risk-based approach initiative for pharmaceutical development initiated in 2004 by the
Food and Drug Administration (FDA, USA) paved the way for the Quality by Design …

The legislations have almost frozen the processes used in pharmaceutical manufacturing
overtime. Even after the receipt of drugs' permits/certificates, even a small change in the …

QbD offers several unique benefits, including deep material and process understanding,
flexibility change within the design space without post-approval, application of effective …