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<p>This paper examines the standardization of bioequivalence (BE) administration methods for chewable tablets and other dosage forms instructing chewing in alignment for generic drug development. It summarizes FDA’s systematic efforts in updating the product-specific guidances (PSGs) of chewable tablets and tablets with chewing instructions. These include the approved administration methods, such as when a product can be chewed or swallowed whole, and whether the product can be administered with and without water as reflected in the reference listed drug (RLD) labeling. The PSGs were updated with the appropriate administration instruction per the recently published FDA guidance for industry <i>Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA</i> (hereafter referred to as FDA BE (ANDA) guidance) and <i>M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms</i> (hereafter referred to as FDA M13A guidance). Based on analysis of current FDA guidance and industry practices, this work supports generic drug development and approval processes for chewable tablet formulations.</p>

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Standardizing bioequivalence administration methods for chewable tablets: aligning product-specific guidance with current FDA recommendations

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月20日

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  • Hye Lim Lim,
  • Heather Boyce,
  • Qi Zhang,
  • Myong-Jin Kim,
  • Wei-Jhe Sun

摘要

This paper examines the standardization of bioequivalence (BE) administration methods for chewable tablets and other dosage forms instructing chewing in alignment for generic drug development. It summarizes FDA’s systematic efforts in updating the product-specific guidances (PSGs) of chewable tablets and tablets with chewing instructions. These include the approved administration methods, such as when a product can be chewed or swallowed whole, and whether the product can be administered with and without water as reflected in the reference listed drug (RLD) labeling. The PSGs were updated with the appropriate administration instruction per the recently published FDA guidance for industry Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (hereafter referred to as FDA BE (ANDA) guidance) and M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms (hereafter referred to as FDA M13A guidance). Based on analysis of current FDA guidance and industry practices, this work supports generic drug development and approval processes for chewable tablet formulations.