Skip to main content
2024 Annual Meeting Main banner
Final Program


Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back

Clinical Trial Designs
Symposia

Symposium 8: Harmonization of the Bioequivalence Assessments for Narrow Therapeutic Index Drugs: Delivering the Promise to Patients

Monday, September 9, 2024
1:30 PM – 3:00 PM ET
Location:Grand Ballroom D
CE: 1.5

    Co-Chair & Faculty(s)

  • Yu Chung Tsang, PhD (he/him/his)

    President
    YCT Scientific Inc

    Slides

  • Lei Zhang, PhD

    Deputy Director
    Office of Research & Standards, Office of Generic Drugs, Ctr for Drug Evaluation & Research
    US Food & Drug Administration

    • Faculty(s)

  • Wenlei Jiang, PhD

    Senior Advisor for Innovation & Strategic Outreach
    Office of Regulatory Science, Office of Generic Drugs, Ctr for Drug Evaluation & Research
    US Food & Drug Administration

  • Paulo Paixao, PhD

    Assistant Professor (Also a European Medicines Agency National Expert)
    Research Inst for Medicines, Faculty of Pharmacy
    Univ of Lisbon

  • Lanyan (Lucy) Fang, PhD

    Deputy Director, Quantitative Methods & Modeling, Research & Standards, Generic Drugs, Ctr for Drug Evaluation & Research
    US Food & Drug Administration

Target Audience:

The target audience for this Symposium is PharmDs, MDs and PhDs with expertise in clinical practice, patient care, drug development, regulatory assessment and research in the area of pharmacometrics, biostatics, pharmacokinetics, regulatory science and generic drugs.



Description:

To support efficient generic drug development, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use recently published the first draft guideline, ICH M13A, in a series of guidelines that describes the scientific and technical aspects of study design and data analysis to support bioequivalence (BE) assessment for orally administered immediate-release (IR) solid oral dosage forms (https://database.ich.org/sites/default/files/ICH_M13A_Step2_draft_Guideline_2022_1125.pdf). The third guideline in the series, ICH M13C, is outlined to include data analysis and BE assessment for drugs with narrow therapeutic index (NTI).

NTI drugs generally refer to drug products where minor differences in dose or blood concentration may lead to serious therapeutic failures and/or adverse drug reactions that are life-threatening or result in significant disability. Currently, different regulatory agencies have different terminology, definition and classification process for NTI drugs. In addition, very different study design and criteria are used for BE demonstration of NTI drugs, hampering global development for these products, increasing cost and limiting product market availability.

The objectives of this session are to understand harmonization needs of NTI drugs, clarify the difference in NTI classification among different regulatory agencies, compare pros and cons of different NTI BE assessment criteria, collect clinical pharmacology experts’ input on the harmonization direction and provide data-driven, science-based recommendation for harmonization consideration.

Consistencies among NTI classification and BE criteria globally can enhance patients and healthcare providers’ confidence regarding generic NTI drug substitution, decrease drug development and assessment time and costs and potentially improve global access to affordable NTI drug products.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Describe the challenges in classification of NTI drug products and further efforts necessary for consistent NTI classification globally;
  • Restate pharmaceutical industry’s perspectives on harmonization needs of Narrow Therapeutic Index (NTI) drugs;
  • Describe the strengths and limitations of different bioequivalence approaches and criteria for NTI drugs as well as potential harmonization direction.

Presentations:

  • Introduction & Overview: Current Regulatory Horizon of Narrow Therapeutic Index Drugs & ICH Guideline Development for Bioequivalence Assessment

    Co-Chair & Faculty: Lei Zhang, PhD – US Food & Drug Administration

  • US FDA Narrow Therapeutic Index Drug Classification: Current Process & Research

    Faculty: Lanyan (Lucy) Fang, PhD – US Food & Drug Administration

  • Industry's Perspectives on Classification Criteria & Bioequivalence Standards for Narrow Therapeutic Index Drugs & the Need for Global Harmonization

    Co-Chair & Faculty: Yu Chung Tsang, PhD (he/him/his) – YCT Scientific Inc

  • A Proposed Approach for the Determination of the Bioequivalence Acceptance Range for Narrow Therapeutic Index Drugs in the European Union

    Faculty: Paulo Paixao, PhD – Univ of Lisbon

  • Data-driven & Science-based Recommendation on Harmonization of Bioequivalence Standards for Narrow Therapeutic Index Drugs

    Faculty: Wenlei Jiang, PhD – US Food & Drug Administration

  • Discussion, Questions & Answers, Learner Feedback & Evaluations