Analysis of the designs of Phase II and III efficacy trials for HPV vaccines suggest they overstated their effectiveness against cervical cancer, according to researchers.
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Scientists have found a way to effectively transport medication into the brain which could lead to improved treatments for neurological and neurodegenerative diseases.
The biotechnology industry is expected to increase the production of new biopharmaceuticals.1 Biopharmaceuticals require high-quality standards, high initial investments for approval and introduction into the market as well as continued investment in manufacturing.2,3
The importance of critical quality attributes in Quality by Design for rapid bioprocess development strategies
QbD and PAT could revolutionise the way biopharma industries operate by cutting down their attrition rates, which could drastically change their business model. This article considers the issues involved.
From data to knowledge through smart Process Analytical Technologies (PAT) and process systems engineering
3 December 2008 | By
Pharma-Chem and bio-pharma development and production are now being profoundly influenced by the FDA PAT1 initiative with spectroscopic instrumentation being increasingly applied, or at the very least explored in product and process development and for on-line real-time process applications. The issues related to robust spectroscopic data analysis and calibration modelling…