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Volume 16 Issue 2
 
Clinical Trials in Slovakia
Editorial Archive

Clinical Trials in Slovakia

The history of clinical trials in Slovakia goes back to the mid- 1990s and the quality has been improving since the beginning. In the last couple of years we have rea...
10 April 2017 Editorial Archive | Volume 9 Issue 2
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Selection of Challenge Agent is Key to Vaccine Development
Editorial Archive

Selection of Challenge Agent is Key to Vaccine Development

Influenza viruses are commonly used in human challenge studies. Both the viruses and the disease they cause are well understood, and the induced illness is short-last...
10 April 2017 Editorial Archive | Volume 9 Issue 2
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Maximising Value in the Rare Disease Sector: Begin with the End in Mind
Editorial Archive

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

Interest in the development of medicines to alleviate or cure rare diseases has increased due to positive actions taken by global regulatory agencies. Alastair MacDon...
10 April 2017 Editorial Archive | Volume 9 Issue 2
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FDA Clarifies Clinical Pharmacology Studies to Support Biosimilarity
Editorial Archive

FDA Clarifies Clinical Pharmacology Studies to Support Biosimilarity

As defined by section 351(k) of the Public Health Service (PHS) Act, a biosimilar product is highly similar to its reference product, “notwithstanding minor diff eren...
10 April 2017 Editorial Archive | Volume 9 Issue 2
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