The AAPS Journal

, Volume 14, Issue 3, pp 627–638 | Cite as

Summary Workshop Report: Facilitating Oral Product Development and Reducing Regulatory Burden Through Novel Approaches to Assess Bioavailability/Bioequivalence

  • James E. Polli
  • Jack A. Cook
  • Barbara M. Davit
  • Paul A. Dickinson
  • Domenick Argenti
  • Nancy Barbour
  • Alfredo García-Arieta
  • Jean-Marie Geoffroy
  • Kerry Hartauer
  • Shoufeng Li
  • Amitava Mitra
  • Francis X. Muller
  • Vivek Purohit
  • Manuel Sanchez-Felix
  • John W. Skoug
  • Kin Tang
Meeting Report Theme: Facilitating Oral Product Development and Reducing Regulatory Burden through Novel Approaches to Assess Bioavailability/B


This summary workshop report highlights presentations and over-arching themes from an October 2011 workshop. Discussions focused on best practices in the application of biopharmaceutics in oral drug product development and evolving bioequivalence approaches. Best practices leverage biopharmaceutic data and other drug, formulation, and patient/disease data to identify drug development challenges in yielding a successfully performing product. Quality by design and product developability paradigms were discussed. Development tools include early development strategies to identify critical absorption factors and oral absorption modeling. An ongoing theme was the desire to comprehensively and systematically assess risk of product failure via the quality target product profile and root cause and risk analysis. However, a parallel need is reduced timelines and fewer resources. Several presentations discussed applying Biopharmaceutics Classification System (BCS) and in vitroin vivo correlations in development and in post-development and discussed both resource savings and best scientific practices. The workshop also focused on evolving bioequivalence approaches, with emphasis on highly variable products (HVDP), as well as specialized modified-release products. In USA, two bioequivalence approaches for HVDP are the reference-scaled average bioequivalence approach and the two-stage group-sequential design. An adaptive sequential design approach is also acceptable in Canada. In European Union, two approaches for HVDP are a two-stage design and an approach to widen C max acceptance limits. For some specialized modified-release products, FDA now requests partial area under the curve. Rationale and limitations of such metrics were discussed (e.g., zolpidem and methylphenidate). A common theme was the benefit of the scientific and regulatory community developing, validating, and harmonizing newer bioequivalence methodologies (e.g., BCS-based waivers and HVDP trial designs).


Area Under Curve Biopharmaceutics Classification System Bioequivalence Study Paliperidone Palmitate Biopharmaceutics Classification System Class 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Copyright information

© American Association of Pharmaceutical Scientists 2012

Authors and Affiliations

  • James E. Polli
    • 1
  • Jack A. Cook
    • 2
  • Barbara M. Davit
    • 3
  • Paul A. Dickinson
    • 4
  • Domenick Argenti
    • 5
  • Nancy Barbour
    • 6
  • Alfredo García-Arieta
    • 7
  • Jean-Marie Geoffroy
    • 8
  • Kerry Hartauer
    • 9
  • Shoufeng Li
    • 10
  • Amitava Mitra
    • 11
  • Francis X. Muller
    • 12
  • Vivek Purohit
    • 2
  • Manuel Sanchez-Felix
    • 9
  • John W. Skoug
    • 13
  • Kin Tang
    • 14
  1. 1.University of Maryland School of PharmacyBaltimoreUSA
  2. 2.Pfizer Global Research and DevelopmentNew LondonUSA
  3. 3.Food and Drug AdministrationCenter for Drug EvaluationRockvilleUSA
  4. 4.Clinical Pharmacology and PharmacometricsAstraZeneca R&DMacclesfieldUK
  5. 5.Janssen Pharmaceutical Research and DevelopmentRaritanUSA
  6. 6.Bristol-Myers Squibb CompanyPrincetonUSA
  7. 7.Agencia Española de Medicamentos y Productos SanitariosMadridSpain
  8. 8.Takeda Global Research & Development CenterDeerfieldUSA
  9. 9.Eli Lilly and CompanyIndianapolisUSA
  10. 10.Novartis Pharmaceuticals CorporationEast HanoverUSA
  11. 11.Merck and Company, Inc.West PointUSA
  12. 12.GlaxoSmithKline PharmaceuticalsCollegevilleUSA
  13. 13.Abbott LaboratoriesAbbott ParkUSA
  14. 14.Hoffmann-La Roche Inc.NutleyUSA

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