ICH Drafts New Guideline on Bioequivalence Testing for Solid Oral Drugs
The International Council for Harmonization (ICH) has released a first draft of a new guideline that offers parameters for bioequivalence (BE) studies of immediate-release solid oral drugs, including considerations for selecting study participants.
The 27-page document, M13A, describes the scientific and technical aspects of study design and data analysis that should be used to support BE assessments during both development and postapproval trials of oral immediate-release dosage forms. The draft is the first in a series of three guidelines on the topic that the ICH plans to develop over the next two to three years.
M13A advises that participants in BE studies should be “at least 18 years of age and preferably have a Body Mass Index between 18.5 and 30.0 kg.” It also stipulates that the “risk to women of childbearing potential should be considered, and the investigators should ensure that female participants are not pregnant or lactating during the BE study and the follow-up.”
If the active substance under investigation has harmful side effects deemed unacceptable for healthy participants, the study may instead be conducted “in a targeted patient population under suitable precautions and supervision,” the draft guideline says.
In addition, the ICH calls for a randomized, single-dose, two-period, two-sequence crossover study design when comparing two formulations, “as single-dose studies provide the most sensitive conditions to detect differences in the rate and extent of absorption.”
However, if safety, ethical or tolerability reasons demand, a multiple-dose study may be conducted in healthy patients and alternative study designs are acceptable if scientifically justified, the ICH says.
The number of participants under evaluation in a pivotal BE study should be no fewer than 12 for a crossover study design or 12 per treatment group in a parallel design, the draft guideline says.
ICH member nations now will review and discuss the draft before the organization can vote on a final guideline, most likely in mid-2024.
Read the ICH draft guideline here: https://bit.ly/3VM2amV.