The International Council for Harmonisation (ICH) announced plans to work on three new topics this year covering patient preference studies, non-clinical safety studies for oligonucleotide-based therapeutics and bioequivalence studies for modified release products. The group also touted the release of long-awaited updates to older guidelines in a 20 June announcement following its 12 June meeting in Vancouver, Canada.
ICH announced that a new efficacy guidance, General Considerations for Patient Preference Studies, will address the design, analysis and submission of these studies to supplement information about a product or to inform drug development.
Plans are also in the works to develop a new safety guideline, Nonclinical Safety Studies for Oligonucleotide-based Therapeutics, to clarify regulatory expectations on the nonclinical evaluation of oligonucleotide-based treatment options. ICH also plans to develop a new multidisciplinary guide, Bioequivalence for Modified-Release Products, to harmonize bioequivalence standards for more complex dosage forms…
