M13B – Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver

Part of the foreseen ICH M13 Guideline series (M13A-C), the 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. This guideline is applicable to both development and post approval phases for orally administered immediate-release (IR) solid oral 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 the foreseen series to describe the scientific and technical aspects of demonstrating BE for additional strengths of a drug product, i.e., obtaining waiver(s) for one or more strengths in an application with multiple strengths when BE has been demonstrated for at least one of the strengths following ICH M13A. How regulatory decisions may be made based on BE assessment is out of the scope of this guideline.

Further information can be found in the M13 Concept Paper and Business Plan.

The ICH Harmonised Guideline was finalised under Step 4 in July 1997. This document covers the preclinical safety testing requirements for biotechnological products. It addresses the use of animal models of disease, determination of when genotoxicity assays and carcinogenicity studies should be performed, and the impact of antibody formation on duration of toxicology studies.

An addendum was proposed to provide clarification on S6 and an update of the following topics discussed in the original ICH S6 Guideline: species selection, study design, immunogenicity, reproductive and developmental toxicity and assessment of carcinogenic potential. The Harmonised addendum provides further complementary guidance to the S6 Guideline and helps to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.

The addendum reached Step 4 of the harmonisation process in June 2011 and was integrated as part II in the core Guideline that was then renamed S6(R1).

M13B – Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver

Annexes

Annexes

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