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PROEX 215/17 and 093.7/21), and conformed to EU Directive 2010/63EU and Recommendation 2007/526/EC regarding the protection of animals used for experimental and other scientific purposes, enforced in Spanish law under Real Decreto 1201/2005

This extended protocol adds intermediate dose steps (0.5mg, 3mg, 6mg) that do not appear in the standard clinical trial schedule

The product meets the same USP specification as Hospira identical formula, identical pharmacopeial testing requirements

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Biochem Biophys Res Commun 305(2):278286