International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Ich Harmonised Tripartite Guideline Genotoxicity : a Standard Battery for Genotoxicity Testing of Pharmaceuticals

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Ich Harmonised Tripartite Guideline Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(r2)

Protecting the rights of pediatric research subjects in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

This Comment argues that the parties to the International Conference on Harmonization of Technical Requirements for Regulation of Pharmaceutical Drugs (ITCH) should adopt more specific guidelines for pediatric research than those included in its Good Clinical Practice Guidelines (ICH GCP), and analyzes their attempt to do so in the Draft Guideline on Pediatric Trials. Part I of this Comment out...

International Concil for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Ich Harmonised Guideline General Principles for Planning and Design of Multi-regional Clinical Trials E17

INTERNATIONAL CONCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE Estimands and Sensitivity Analysis in Clinical Trials E9(R1)

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Draft Consensus Guideline