International conference on harmonization of technical requirements for registration of pharmaceuticals for human use

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

Oncolytic viruses (OV) were first observed in early clinical studies in patients with malignancies where tumour regressions were observed to coincide with viral infections or with live virus vaccinations. Since these early reports, studies using OV have progressed from anecdotal and controlled infections to specifically selecting or genetically modifying viruses for cancer treatment. OV are int...

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

The informed-consent policy of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: knowledge is the best medicine.

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

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...