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The Timing of Toxicological Studies to Support Clinical Trials (Paperback, Softcover reprint of the original 1st ed. 1994)
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The Timing of Toxicological Studies to Support Clinical Trials (Paperback, Softcover reprint of the original 1st ed. 1994)
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Over the past twelve years, the Centre for Medicines Research has
held a series of Workshops on a number of topics related to the
drug discovery and development process. The major objective of
these Workshops has been to provide an international forum for
regula tory, academic and industry representatives to debate
together, and suggest solutions to, specific problems. The meeting
reported in this volume represents a departure from this approach,
in that the par ticipants were drawn largely from the
pharmaceutical industry. Senior clinicians, pharmacologists and
toxicologists from companies in Europe, the USA and Japan met in
May 1994 to discuss a scientific rationale for the conduct of
toxicity studies to support the clinical development of new
medicines, and to begin to work towards an industry consensus.
Achievement of such a consensus is seen as an important step in the
process leading towards international harmon isation of the
recommendations on the timing of toxicity studies in relation to
clinical trials."
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