Collection: Publications - Clinical
Publications - Clinical
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GMP Manufacturing Handbook
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Good Clinical Practice Handbook
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8-Hour Monthly GMP Training, Certificate, GMP Handbook & e-Workbook
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Medical Device Combination
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21 CFR 320 - Bioavailability and Bioequivalence Requirements
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21 CFR 312, 314, 511 - Human and Animal Drug Approval
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21 CFR 316 - Orphan Drugs
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21 CFR 314 - Applications for FDA Approval to Market a New Drug
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21 CFR 312 - Investigational New Drug Application
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21 CFR 56 - Institutional Review Boards
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21 CFR 54 - Financial Disclosure by Clinical Investigators
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21 CFR 50 - Protection of Human Subjects
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21 CFR 50, 54, 56 - GCP Drug Approval Handbook
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GCLP Good Clinical Laboratory Handbook - 4.5x7.5
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