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

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 …

Biopharmaceuticals already represent a broad field of new and innovative medicines that
promote a longer and healthier life, either by preventing and inhibiting the progression of …

Abstract Quality by Design (QbD) for the pharmaceutical industry includes the design,
development and production control of products and production processes from the …

Quality is one of the fundamental criteria in addition to safety and efficacy for any entity to be
qualified and approved as a drug. For ensuring consistency of performance of …

Evolution and Integration of Quality by Design and Process Analytical Technology Page 1 13
EVOLUTION AND INTEGRATION OF QUALITY BY DESIGN AND PROCESS ANALYTICAL …

Since the beginning of this century, the pharmaceutical industry has been experiencing a
new era that is far more scientific, technologic, and sophisticated than anyone would have …

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 …

The quality of medicines reaching the consumer is strictly controlled and maintained by the
regulatory agencies of the world. Pharmaceutical companies have to meet and maintain …

As with all of pharmaceutical production, the regulatory environment for the production of
therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design …