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Issue 1 2017


Pharmaceutical QbD: Omnipresence in the product development lifecycle

18 April 2017 | By , ,

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’…

Improving the consistency of MDI drug delivery

25 February 2017 | By

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...

NIR In-Depth Focus 2017

22 February 2017 | By

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...

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