International – Genetically altered vaccines developed to help eradicate polio

Polio is a highly infectious viral disease that largely affects children aged under five years. The virus is transmitted by person-to-person and multiplies in...

International – E6(R3): ICH releases draft of overhauled GCP guideline for consultation

The International Council for Harmonisation (ICH) on Tuesday published the long-awaited draft version of its ICH E6(R3) guideline on good clinical practice (GCP) for...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for...

The purpose of this document is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART)...

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