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I. The Role of Clinical Pathology in the Drug Development Process |
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A. Clinical Pathology and Preclinical Studies |
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B. Clinical Pathology and Clinical Trials |
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C. Integration of Preclinical and Clinical Support |
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II. The Choice of Clinical Pathology Laboratories |
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III. Quality, Accreditation, and Data Archiving |
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IV. Progressive Restructuring of Clinical Pathology at Zeneca to Support Clinical Trials |
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A. Laboratory Changes Required to Accommodate the Additional Workload |
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B. Sample Stability for Clinical Chemistry and Hematology Analyses |
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V. Clinical Pathology Support of Phase I: Safety and Tolerance Trials |
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