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Guidances

Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications Guidance for Industry

In Vitro Metabolism- and Transporter- Mediated Drug-Drug Interaction Studies Guidance for Industry

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Other Related Clinical Pharmacology Guidances

  1. Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry (PDF - 92 KB) (Posted 12/01/16)
  2. Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (PDF - 221 KB) (Posted 05/5/2003)
  3. Population Pharmacokinetics (PDF - 135 KB) (Posted 02/10/1999)
  4. Pharmacogenomic Data Submissions (PDF - 307 KB) (Posted 03/01/2005)

Labeling

  1. Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 144KB) (Posted 12/02/16)
  2. Labeling for Human Prescription Drug and Biological Products — Implementing PLR Content and Format Requirements (PDF - 527KB) (Posted 02/22/2013)
  3. Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 102KB) (Posted 10/11/2011)

Manual of Policies and Procedures (MaPP)

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Good Review Practices: Clinical Pharmacology Review of New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) (PDF - 307KB) (Posted 09/22/16)