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Journal for Clinical Studies
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Category Archives: Editorial Archive

Clinical Trials in Slovakia

Editorial Archive, Volume 9 Issue 2By Admin10th April 2017

The history of clinical trials in Slovakia goes back to the mid- 1990s and the quality has been improving since…

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Selection of Challenge Agent is Key to Vaccine Development

Editorial Archive, Volume 9 Issue 2By Admin10th April 2017

Influenza viruses are commonly used in human challenge studies. Both the viruses and the disease they cause are well understood,…

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Maximising Value in the Rare Disease Sector: Begin with the End in Mind

Editorial Archive, Volume 9 Issue 2By Admin10th April 2017

Interest in the development of medicines to alleviate or cure rare diseases has increased due to positive actions taken by…

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FDA Clarifies Clinical Pharmacology Studies to Support Biosimilarity

Editorial Archive, Volume 9 Issue 2By Admin10th April 2017

As defined by section 351(k) of the Public Health Service (PHS) Act, a biosimilar product is highly similar to its…

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Demand-led Supply: Increasing Efficiency in Clinical Studies Logistics

Editorial Archive, Volume 9 Issue 1By Admin13th February 2017

Cost pressures associated with the development of new medications are at an all-time high for the pharmaceutical industry. Drug development…

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How Integration of Consumer and Medical Devices is Reshaping Clinical Trials

Editorial Archive, Volume 9 Issue 1By Admin13th February 2017

The advent of continuous data monitoring using wearable technology and other connectable medical devices has opened the door to new…

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Why would Cardiovascular Outcomes Trials and Rare Disease Studies have Anything in Common?

Editorial Archive, Volume 9 Issue 1By Admin13th February 2017

Cardiovascular outcomes trials (CVOTs) are some of the largest interventional trials being conducted, enrolling several thousand subjects, sometimes with follow-up…

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Bridging the Clinical Data Structure Gap to Empower Holistic Risk Management

Editorial Archive, Volume 9 Issue 1By Admin13th February 2017

Per the suggestion of regulatory agencies, there is an increased focus on the merits of adapting a risk-based monitoring (RBM)…

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Why and How a Research Lab Should Embrace Research Quality

Editorial Archive, Volume 9 Issue 1By Admin13th February 2017

The development of therapeutic products balances benefits and adverse consequences, so research quality is required for the development of the…

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Latest FDA Guidance on Non-Inferiority Designs

Volume 9 Issue 1By Admin13th February 2017

To obtain drug approval from the US Food and Drug Administration (FDA), manufacturers must establish efficacy by providing “substantial evidence”…

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