Substantial changes in Pharmaceutical R&D strategy are required to address existing issues
of low productivity, imminent patent expirations and pressures on pricing. Moves towards …

The regulatory and technical landscape of the pharmaceutical field is rapidly evolving from
one focused predominantly on development of small molecules, using well established …

Quality has always been a key focus for the pharmaceutical industry, with drug developers
traditionally using late-stage quality testing to ensure medicines are safe, reliable, and …

A practical guide to Quality by Design for pharmaceutical product development
Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven …

Highlights•Extension of the ICH Q8 “Quality by Design (QbD)” model.•Enlarged QbD
pathway for answering the challenges of drug R&D and industrial production.•Model …

Quality by Design (QbD) must currently be considered one of the critical topics for the
pharmaceutical industry. While QbD and the associated standards are, by any measure, a …

Pharmaceutical quality has been under long debate for decades. In the current scenario of
regulatory environments, the pharmaceutical industry is continuously facing challenges with …

Recently, the pharmaceutical industry has been facing several challenges associated to the
use of outdated development and manufacturing technologies. The return on investment on …

Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading
to an escalating number of product recalls and rejects. Due to the involvement of multiple …

Covers a widespread view of Quality by Design (QbD) encompassing the many stages
involved in the development of a new drug product. The book provides a broad view of …