ICH guideline M13B on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Scientific guideline
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ICH M13B guideline is intended to provide recommendations on obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both development and post-approval phases of orally administered immediate release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.
The ICH M13B guideline is the second guideline in a foreseen ICH series describing the scientific and technical aspects of study design and data analysis to support BE assessment for orally administered IR solid oral dosage forms. For more information on international harmonisation of BE, please refer to the dedicated ICH M13 page.
On 17 March 2027, ICH M13B comes into effect and supersedes applicable parts of the current EMA guideline related to additional strength biowaivers.
Specific considerations to enable the practical application of ICH Guideline M13B in the European Union and the transition from the EMA guideline will be published shortly and will be available in the section below.
Keywords: bioequivalence, clinical trials, immediate release, oral dosage forms, pharmacokinetics, strength biowaiver