Current Edition

FDA efficacy recommendations
Volume 10 Issue 2

FDA Efficacy Recommendations Vary for Hypogonadotropic Hypogonadism Drugs

This article, written by Meg Egan Auderset at Clarivate Analytics, describes how the new draft industry guidance from the US Food and Drug Administration (FDA) …

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Ensuring launch success in rare disease
Volume 10 Issue 2

Ensuring Launch Success in Rare Disease Areas by Creating a Value Story

A number of trends (both in science and on the regulatory front) bode well for the development and availability of drugs to treat rare diseases. …

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Clinical trials in Russia
Volume 10 Issue 2

Clinical Trials in Russia – Report on Q3 of 2017

The Russian MoH approved 158 new clinical trials of all types including local and bioequivalence studies during Q3 2017, demonstrating a 34% decrease in comparison …

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Combined studies under the new EU
Volume 10 Issue 2

Combined Studies Under the New EU Clinical Trial Regulation

The key aim of the new EU Clinical Trial Regulation, which is currently planned for implementation in mid-2019, is to boost clinical research in the …

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Pediatric melanoma and the pharmaceutical
Volume 10 Issue 2

Paediatric Melanoma and the Pharmaceutical Industry

The age of paediatric melanoma used to be a theoretical discussion, but has become a real-life challenge due to arbitrary age limits decreed by regulatory …

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A review of FDA's updated guidance
Volume 10 Issue 2

A Review of FDA’s Updated Guidance for Developing Drugs to Treat Early Alzheimer’s Disease

There has been a renewed interest in clinical trials of drugs to treat early Alzheimer’s disease, owing partially to recent advances in the understanding of pathophysiological …

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Clinical trials down under Australia&New Zealand
Volume 10 Issue 2

Clinical Trials Down Under Australia and New Zealand – A Competitive Region

The Australian clinical trials landscape has developed considerably over recent years with over 1000 new clinical trials commencing each year in the pharmaceutical, biotechnology and …

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Russian clinical trials market
Volume 10 Issue 2

Russian Clinical Trials Market in 2017

Following on from the last article featured by Svetlana Zavidova from the Association of Clinical Trials Organizations (ACTO) in the July 2017 JCS on clinical …

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Developing talent for the future
Volume 10 Issue 2

Developing Talent for the Future of Clinical Research

Clinical research is a rapidly evolving and dynamic environment and the sector is undergoing significant changes on a number of fronts. The wider use of …

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How to rescue a clinical trials
Volume 10 Issue 2

How to Rescue a Clinical Trial, if You Must

Conducting a clinical trial is a huge and complex undertaking, and there are, more often than not, challenges. And in an undertaking as scientifically and …

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