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ICH M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

ICH S6 - Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

Updated 2024 - 21 CFR 50, 54, 56 - GCP Drug Approval Handbook

21 CFR 54 - Financial Disclosure by Clinical Investigators

ICH E2A - Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

ICH E8 - General Considerations for Clinical Studies

ICH E6(R2) - Good Clinical Practice

21 CFR 320 - Bioavailability and Bioequivalence Requirements

ICH Q2(R2) and ICH Q14 Analytical Validation

Parts 11, 606 and 1271 - Blood Cell & Tissue GMPs

Parts 11, 606 and 1271 - Blood, Cell & Tissue with Annex 14

In Vitro Diagnostics Master Handbook

VICH GL9 Animal GCP

Title 21 CFR Parts 1 - End Nine Volume Set

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