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Amarin receives special protocol assessment agreement

Amarin announced that it has reached agreement with the U.S. FDA under a Special Protocol Assessment for its planned Phase 3 clinical trial of AMR101 in patients with mixed dyslipidemia.



Special protein helps maintain an efficient brain

The instruction manual for maintaining an efficient brain may soon include a section on synaptotagmin-IV (Syt-IV), a protein known to influence learning and memory.



How to meet the special design and quality needs of biopharm

Regulations and time-to-market pressures leave little room for error in the biopharm market ­ but design quality, schedule and deliverables can all be enhanced using 3D technology, says Dean Martyniak.



Special titration PC software released to comply with FDA requirements

The need for pharmaceutical laboratories to comply with Title21 of the Code of Federal Regulations Part11 is an increasingly important issue. It generates many requests for a21CFRPart11 compliant' software, despite the fact it is the laboratory that has to be in compliance with the regulations, rather than the software.



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