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Oct 13, 2003
 |  BioCentury  |  Product Development

Trapped to the max

Companies faced with manufacturing or formulation constraints early in the clinical development of a compound have a tough decision to make. Should they wait to run dose-ranging trials until they can manufacture enough product to push the dose to the limit? Or should they go ahead and possibly under-dose, running the risk that results will be inconclusive, and thus won't provide clear guideposts for Phase III trials?
Higher doses weren't used for the Phase II trial, because "at the time that was the most we could deliver," said Leonard Schleifer, president and CEO of REGN (Tarrytown, N.Y.)....

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