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JCS Volume 15 Issue 3
 
The Comprehensive In Vitro Proarrhythmia Assay: An Update
Volume 10 Issue 4

The Comprehensive In Vitro Proarrhythmia Assay: An Update

While the International Council on Harmonisation (ICH) S7B/E14 regulatory landscape has successfully prevented new drugs with an unrecognised propensity to induce the...
28 August 2018 Volume 10 Issue 4
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Success with Adaptive Registries in Rare Disease Research
Volume 10 Issue 4

Success with Adaptive Registries in Rare Disease Research

Clinical research in rare diseases has become intensely competitive, with stakes that are high both for sponsors and patients. Sean Kennedy at Syneos Health describes...
28 August 2018 Volume 10 Issue 4
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Working with the Regulators
Volume 10 Issue 4

Working with the Regulators

Regulators such as the FDA and EMA are often perceived as roadblocks on the route to drug approval. Their role is not to make life for drug developers difficult, as t...
28 August 2018 Volume 10 Issue 4
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Developing Brown Fat Treatment for Tackling Obesity
Volume 10 Issue 4

Developing Brown Fat Treatment for Tackling Obesity

Obesity has now reached epidemic levels worldwide. Consequently, there has been an alarming upsurge in major non-communicable diseases including type 2 diabetes, non-...
28 August 2018 Volume 10 Issue 4
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Draft Guidance Addresses Inclusion of Adolescents in Oncology Trials
Volume 10 Issue 4

Draft Guidance Addresses Inclusion of Adolescents in Oncology Trials

With an eye toward helping industry, investigators, and institutional review boards (IRBs), the US Food and Drug Administration (FDA) has unveiled draft guidance on t...
28 August 2018 Volume 10 Issue 4
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The Impact of the New European Union Medical Devices Regulation (EU MDR) 2017/745 and MDR 2017/746
Volume 10 Issue 4

The Impact of the New European Union Medical Devices Regulation (EU MDR) 2017/745 and MDR 2017/746

The European Economic Area (EEA) – which includes the European Union (EU) and three of the four states of the European Free Trade Association (EFTA) – has long been c...
28 August 2018 Volume 10 Issue 4
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Writing Pediatric Study Plans (PSPs) – The Impact of the Revised 2016 FDA Draft Guidance
Volume 10 Issue 4

Writing Pediatric Study Plans (PSPs) – The Impact of the Revised 2016 FDA Draft Guidance

Children make up approximately one-quarter of the world’s population, but despite this the majority of drugs used in children are usually prescribed ‘off-label’ and h...
28 August 2018 Volume 10 Issue 4
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Advantages and Challenges of Outsourcing Post-marketing Study Activities
Volume 10 Issue 4

Advantages and Challenges of Outsourcing Post-marketing Study Activities

In the past, life science companies went through numerous clinical trial phases before gaining market approval and launching their products. Once those products were ...
28 August 2018 Volume 10 Issue 4
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Clinical Trials in Russia – Report On 2017
Volume 10 Issue 4

Clinical Trials in Russia – Report On 2017

Igor Stefanov at Synergy Research Group reveals that the Russian MoH approved 700 new clinical trials of all types including local and bioequivalence studies during 2...
28 August 2018 Volume 10 Issue 4
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Transparency and Public Interest: Striking a Balance
Volume 10 Issue 4

Transparency and Public Interest: Striking a Balance

As from next year, life sciences firms will be expected to prepare plainlanguage summaries (PLSs) for all Phase I–IV interventional trials, to comply with requirement...
28 August 2018 Volume 10 Issue 4
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