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CSR Addendum Documents

Safety Narratives

Electronic Publishing
(Granular eCTD or Legacy NeeS)

  • ADME
  • First in Human (SAD and MAD)
  • Bioavailability and Bioequivalence
  • Drug-Drug Interaction
  • Food Effect
  • Hepatic and Renal Impairment
  • Pharmacokinetics/ Pharmacodynamics
  • Immunogenicity and Biomarkers
  • Thorough QTc (TQT)
  • ADME
  • First in Human (SAD and MAD)
  • Bioavailability and Bioequivalence
  • Drug-Drug Interaction
  • Food Effect
  • Hepatic and Renal Impairment
  • Pharmacokinetics/Pharmacodynamics
  • Immunogenicity and Biomarkers
  • Thorough QTc (TQT)

Investigator Brochures

IND Support

Trial Registration and
Results Disclosure

Protocols and Protocol Amendments

Phase 1–3 Full and Synoptic Integrated Clinical Study Reports (CSRs) including:


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