Patient Preference, Safety Evaluation, Bioequivalence New Guidance Areas for ICH
The International Council for Harmonisation’s (ICH) governing group announced earlier this month it will begin work on new guidelines in three areas: patient preference, nonclinical safety evaluation for oligonucleotide-based therapies and bioequivalence for modified-release products.
“General Considerations for Patient Preference Studies” will be an efficacy guideline offering advice on systematically designing, conducting, analyzing and presenting patient preference studies to support information about a product’s assessment or a drug’s development and related decisions.
“Nonclinical Safety Studies for Oligonucleotide-based Therapeutics” will be a safety guideline clarifying regulatory expectations for nonclinical safety evaluations of various oligonucleotide-based therapies and offer a “common understanding” of requirements.
“Bioequivalence for Modified-Release Products” will be a multidisciplinary guideline that will serve to harmonize bioequivalence standards for more complex dosage forms.
ICH has not yet determined when development of the guidelines, which typically takes several years, will begin.
The council also announced formation of a new discussion group on cell and gene therapies that will develop a plan for new guidelines on related issues that need harmonization.
Read the ICH announcement at https://bit.ly/44d3oMz.