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BioPharmaceutical Regulation

Why Phase III Still Matters

  • Analysis

Executive Summary

Avycaz dosing for renally impaired patients was carefully considered based on sophisticated PK/PD analysis and Phase II data used to support its expedited limited use approval. Even so, the Phase III trials still uncovered a problem.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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