The publication detail shows the title, authors (with indicators showing other profiled authors), information on the publishing organization, abstract and a link to the article in PubMed. This abstract is what is used to create the fingerprint of the publication. If any grants are referenced by the publication, they will be listed here as well.
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; et al. (Profiled Author: James E. Polli)
University of Maryland School of Pharmacy, Baltimore, Maryland 21201, USA. email@example.com
The AAPS journal 2012;14(3):627-38.
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 vitro-in 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).
This section shows information related to the publication - computed using the fingerprint of the publication - including related publications, related experts and related grants with fingerprints representing significant amounts of overlap between their fingerprint and this publication. The red dots indicate whether those experts or terms appear within the publication, thereby showing potential and actual connections.
James E Polli; Bertil S I Abrahamsson; Lawrence X Yu; Gordon L Amidon; John M Baldoni; Jack A Cook; Paul Fackler; Kerry Hartauer; Gordon Johnston; Steve L Krill; et al.The AAPS journal 2008;10(2):373-9.
Igor E Shohin; Julia I Kulinich; Galina V Ramenskaya; Bertil Abrahamsson; Sabine Kopp; Peter Langguth; James E Polli; Vinod P Shah; D W Groot; Dirk M Barends; et al.Journal of pharmaceutical sciences 2012;101(10):3593-603.
Jennifer B Dressman; Anita Nair; Bertil Abrahamsson; Dirk M Barends; D W Groot; Sabine Kopp; Peter Langguth; James E Polli; Vinod P Shah; Markus ZimmerJournal of pharmaceutical sciences 2012;101(8):2653-67.
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