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The concept of Quality by Design (QbD) was implemented by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and United States Food and Drug Administration (FDA) around a decade ago, with the aim of adopting systematic approaches for developing high-quality pharmaceutical products for patients’…
A defining characteristic of inhaled drug delivery is variability in the dose received by the patient, as a result of physiology, for example, or the technique applied during use. This variability directly affects clinical outcomes so reducing it to a minimum is an important goal for the industry...
For the pharmaceutical scientist, the journey of an active molecule from the end of its synthetic pathway and crystallisation to its ultimate site of action is a fascinating one, and one that is necessary to understand...
Commercial biomanufacturing dates to thousands of years and the first biological engine, the yeast, continues to be beneficial...
Near-infrared spectroscopy (NIRS) is used by the pharmaceutical industry for a wide variety of applications, including the identification of drug substances, products and raw materials; tablet assays; uniformity of content; water content; solid state form; and process analytical technologies...
Near-infrared spectroscopy (NIRS) is a rapid and non-destructive analytical technique that is important in analysing or profiling both solid and liquid dosage forms, as well as biotechnological products...
Read the free-to-view digital version of the latest issue of European Pharmaceutical Review...
Pharmaceutical QbD: Omnipresence in the product development lifecycle; Expert View with Kaiser Optical Systems Inc.; and Reinventing commercial biomanufacturing...
In this NIR In-Depth Focus: Monitoring and controlling drug products and manufacturing processes with NIRS; Development of a NIRS method for quantification of a minor polymorphic form; and an Expert View with Metrohm Process Analytics...
Understanding the effect of API changes in pharmaceutical processing; Improving the consistency of MDI drug delivery; and Expert Views with DDF Summit and Eurofins Lancaster Laboratories...
In this Guide to QA/QC Instrumentation, we consider the Sievers M9 series of TOC Analyzers from GE Analytical Instruments, and METTLER TOLEDO’s UV7 Spectrophotometer...
The British Pharmacopoeia (BP) is a collection of authoritative and publicly available quality standards for medicines, supported by guidance and additional value-adding information. First published in 1864, the BP has an illustrious history that has been built on quality and continually responds to the needs of stakeholders and users.
The first part of an in-depth article on Quality by Design (QbD), published in European Pharmaceutical Review in December 2016, focused on designing quality in to a pharmaceutical drug product by considering dosage form design, and understanding the importance of active pharmaceutical ingredients’ (APIs’) and excipients’ properties.
In the context of clinical trial data disclosure, since 2010 the regulatory impetus has shifted towards enhanced disclosure obligations, culminating in the publication of a ‘pro-active’ policy on the publication of clinical trial data for medicinal products for human use1 (Policy 0070) by the European Medicines Agency (EMA) in October…
