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Harmonised

S2 – Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use

In Process

S2 – Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use

Pre-harmonisation

S2 – Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use

Harmonised

S3A – Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies

In Process

S3A – Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies

Pre-harmonisation

S3A – Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies

Harmonised

S3B – Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies

In Process

S3B – Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies

Pre-harmonisation

S3B – Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies

Harmonised

S4 – Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)

In Process

S4 – Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)

Pre-harmonisation

S4 – Duration of Chronic Toxicity Testing in Animals (Rodent and Non Rodent Toxicity Testing)

Harmonised

S5 – Detection of Toxicity to Reproduction for Human Pharmaceuticals

In Process

S5 – Detection of Toxicity to Reproduction for Human Pharmaceuticals

Pre-harmonisation

S5 – Detection of Toxicity to Reproduction for Human Pharmaceuticals

Harmonised

S7A – Safety Pharmacology Studies for Human Pharmaceuticals

In Process

S7A – Safety Pharmacology Studies for Human Pharmaceuticals

Pre-harmonisation

S7A – Safety Pharmacology Studies for Human Pharmaceuticals

Harmonised

S7B – The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

In Process

S7B – The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

Pre-harmonisation

S7B – The Non-Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals

Harmonised

S8 – Immunotoxicity Studies for Human Pharmaceuticals

In Process

S8 – Immunotoxicity Studies for Human Pharmaceuticals

Pre-harmonisation

S8 – Immunotoxicity Studies for Human Pharmaceuticals