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Journal for Clinical Studies
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Category Archives: Editorial Archive

The Role of Regulatory Agencies in New Drug Development: A Global Perspective

Regulatory, Volume 6 Issue 1By Admin12th February 2014

Regulatory agencies worldwide play a critical role in healthcare as independent reviewers and approvers of applications made by sponsors to…

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Risk-based Monitoring: Moving Forward

Regulatory, Volume 6 Issue 1By Admin12th February 2014

After issuance of the final guidance document by FDA on Oversight of Clinical Investigations – A Risk-based Approach to Monitoring,…

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Regulation for Paediatric Drug Development in India: Need of the Hour

Regulatory, Volume 6 Issue 1By Admin12th February 2014

India is a popular location for clinical research due to the multitude of benefits it offers, including a large patient…

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pharma

Our Love/Hate Relationship with Clinical Surveillance, and Why Both are Valid

Editorial Archive, Volume 5 Issue 6, Watch Pages V5 I6By Admin5th December 2013

CNS researchers have implemented surveillance strategies from within pharmaceutical companies, through contract research organizations, or by using one of the…

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An Overview of the Legislative Framework for FDA Expedited Programs for Serious Conditions

Editorial Archive, Volume 5 Issue 6, Watch Pages V5 I6By Admin5th December 2013

On June 26, 2013, the US Food and Drug Administration (FDA) announced in the Federal Register, the publication of a…

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Macroeconomic Forces Driving Clinical Trial Costs

Editorial Archive, Market Report V5 I5, Volume 5 Issue 5By Admin4th December 2013

A lot has been written about the Affordable Care Act (ACA) recently. Key provisions are kicking in over the next…

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Pediatric Patient Retention: It’s not Child’s Play

Editorial Archive, Therapeutics V5 i5, Volume 5 Issue 5By Admin4th December 2013

In June 2013, the European Commission published a report on the first five years of the Paediatric Regulation that came…

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The Role of Central Laboratories in AD Trials

Editorial Archive, Therapeutics V5 i5, Volume 5 Issue 5By Admin4th December 2013

Alzheimer’s disease (AD) is a debilitating neurodegenerative disorder that mainly affects the elderly population. The prevalence of AD is predicted…

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Adjunctive Treatment with Atypical Antipsychotics Among Adolescents with Major Depressive Disorder

Editorial Archive, Therapeutics V5 i5, Volume 5 Issue 5By Admin4th December 2013

Among adolescents, lifetime prevalence estimates for major depressive disorder (MDD) range as high as 8-11%. Depressed adolescents are also at…

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H7N9 Influenza and the Rush to Vaccine Development

Editorial Archive, Volume 5 Issue 5, Watch Pages V5 I5By Admin4th December 2013

On March 31, 2013, the Chinese health authorities announced the first human case of a new strain of avian influenza…

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