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Category Archives: Volume 9 Issue 6

Modern Tools to Advance Generic Drug Development and Review

Editorial Archive, Volume 9 Issue 6By flabio54th December 2017

Generic prescription drugs that are approved by the FDA have the same high quality and strength as brand-name drugs. Likewise,…

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Gene Therapy in Rare Diseases

Editorial Archive, Volume 9 Issue 6By flabio54th December 2017

Many rare diseases are “monogenic” – that is, they are the consequence of a defect in a single gene. Daniel…

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Patient Safety Monitoring and Beyond

Editorial Archive, Volume 9 Issue 6By flabio54th December 2017

Whether enabling new approaches to patient safety monitoring and clinical trials, or improving success rates for regulatory submissions, artificial intelligence…

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FDA Guidance Recommends Diversity in Clinical Trials, but Can’t Require It

Editorial Archive, Volume 9 Issue 6By flabio54th December 2017

The US Food and Drug Administration (FDA) frequently stress the importance of enrolling diverse patient populations in clinical trials conducted…

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Intellectual Property Strategies ‘Crucial’ to Protecting Future of Medical Innovation

Editorial Archive, Volume 9 Issue 6By flabio54th December 2017

Robust intellectual property protection is essential to safeguarding the future of revolutionary biomedical innovations, which transform healthcare for millions of…

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The Lay Summary – Remember the Reader

Editorial Archive, Volume 9 Issue 6By flabio54th December 2017

As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a…

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Regulations and Recruitment: Challenges and Experiences in Bulgaria

Editorial Archive, Volume 9 Issue 6By flabio54th December 2017

Rossen Mihaylov at Ramus Medical discusses the challenges faced during the preparation and conduct of clinical investigations. For both medical…

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eClinical: How One Major BioPharma Company is Embracing the New World of Digital Clinical Research

Editorial Archive, Volume 9 Issue 6By flabio54th December 2017

The major objective of pharmaceutical research & development is to bring new health solutions to people who need them. Lionel…

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Challenges with Cash Management and Reforecasting Clinical Trials

Editorial Archive, Volume 9 Issue 6By flabio54th December 2017

Clinical trials are becoming increasingly complex, particularly with broader scopes, globalisation, changing and expanding regulatory requirements and a greater number…

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Pre-clinical Data Analysis Ensuring Relevant First-in-Human Clinical Trials

Editorial Archive, Volume 9 Issue 6By flabio54th December 2017

The first-in-human trial (FIH) is an important milestone in the development of a potential new drug. Nariné Baririan at SGS…

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