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Issue 1 2017

Issue #1 2017 – Digital version

Issue 1 2017 / 22 February 2017 / European Pharmaceutical Review

Read the free-to-view digital version of the latest issue of European Pharmaceutical Review…

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Biopharmaceutical Development & Processing In-Depth Focus 2017

Issue 1 2017 / 22 February 2017 / European Pharmaceutical Review

Pharmaceutical QbD: Omnipresence in the product development lifecycle; Expert View with Kaiser Optical Systems Inc.; and Reinventing commercial biomanufacturing…

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NIR In-Depth Focus 2017

Issue 1 2017 / 22 February 2017 / European Pharmaceutical Review

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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Formulation Development & Drug Delivery In-Depth Focus 2017

Issue 1 2017 / 22 February 2017 / European Pharmaceutical Review

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…

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Guide to QA/QC Instrumentation

Issue 1 2017 / 22 February 2017 / European Pharmaceutical Review

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…

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The British Pharmacopoeia – in 2017 and beyond

Issue 1 2017 / 22 February 2017 / James Pound, British Pharmacopoeia

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 BP Secretariat is an integral part of the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), strategically located within the Inspection, Enforcement and Standards Division since 2003. As such, it has access to expertise, experience and resources that mean it is well placed to maintain the BP’s strong reputation and build on ongoing successes. 2017 will be an important year for the British Pharmacopoeia (BP), with a number of exciting initiatives and new content being published.

Quality by Design for generic products: opportunities and challenges

Issue 1 2017 / 22 February 2017 / Patrick Crowley, Callum Consultancy and Sean McCrossen, EXA100 Consulting

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 second instalment of this two-part series, […]

Drawing the boundaries of data disclosure in clinical trials

Issue 1 2017 / 22 February 2017 / Maria Isabel Manley and Grant Strachan, Bristows LLP

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 20142 . In addition, legislative action has arrived in the form of the Clinical Trials Regulation 526/2014/EC, which is anticipated to enter into force in October 2018. These recent European Union legislative and policy developments are set to have a major impact on the continuing research and development cultures and practices adopted by the pharmaceutical industry. In particular, the scope of protection for legitimate commercial interests and, specifically, the redaction of commercially confidential information (“CCI”) remains legally uncertain. Indeed, at the time of writing the question remains subject to ongoing litigation before the European Courts.

 

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