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(1) Why the international harmonisation process is increasingly important
In the first of two articles, Robin Harman explains the increasing
importance of the ICH process as the cost of bringing new medicinal
products to the market continues to spiral, and greater pressures
are placed on regulatory authorities to be more efficient
(PDF
130K)
Pharmaceutical Journal, 14 August 2004, 224-226. Vol 273, no
7312
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(2) Rationalising drug development — the international harmonisation process
In the second of two articles, Robin Harman describes the ways in which ICH guidelines
are selected and developed, and the current status of all guidelines that have
been generated
(PDF 130K)
Pharmaceutical Journal, 21 August 2004, 260-262. Vol 273, no 7313
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