What ICH S7A: Safety Pharmacology Studies for Human Pharmaceuticals requires
ICH S7A mandates a core safety pharmacology battery assessing cardiovascular (hERG, telemetry), CNS (Irwin/FOB), and respiratory function for all new pharmaceutical candidates before first human dosing, with follow-up studies required when signals are detected or when the drug mechanism raises concern for any vital organ system.
Pillar: Biotech & Genomics · Authority: ICH Safety Working Party (SWP) - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use · Version: 1.0.0 · Last updated:
Primary source: https://www.ich.org/products/guidelines/safety/safety-single/article/s7a.html
SHA-256 integrity: 32422065847acbbc4039dec6dc3543084cb2c89dd98898bc24f4414441c75cda
Primary Citations — 6 traced to source
- {"title":"ICH S7A: Safety Pharmacology Studies for Human Pharmaceuticals - Step 4 Final Guideline","url":"https://www.ich.org/products/guidelines/safety/safety-single/article/s7a.html","instrument":"ICH S7A (November 2001)","authority":"International Council for Harmonisation (ICH)"}
- {"title":"ICH S7B: The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals","url":"https://www.ich.org/products/guidelines/safety/safety-single/article/s7b.html","instrument":"ICH S7B (May 2005)","authority":"ICH"}
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