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Numrering	Referens	Omslagsbild	Hitta
1.	Chen, Mei-Ling, et al. (författare) Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products : Workshop summary report. 2010 Ingår i: Clinical Therapeutics. - : Elsevier BV. - 0149-2918 .- 1879-114X. ; 32:10, s. 1704-1712 Tidskriftsartikel (refereegranskat)abstract The current regulatory approaches and criteria for bioequivalence evaluation were considered adequate for the assessment of therapeutic equivalence and interchangeability of conventional monophasic MR products. Additional measures may occasionally be needed to establish the bioequivalence of multiphasic MR products, and development of such measures is an important objective. The metric of partial AUC was proposed for products designed to have a rapid drug action followed by sustained response.
2.	Polli, James E, et al. (författare) Summary workshop report : bioequivalence, biopharmaceutics classification system, and beyond 2008 Ingår i: AAPS Journal. - : Springer Science and Business Media LLC. - 1550-7416. ; 10:2, s. 373-379 Tidskriftsartikel (refereegranskat)abstract The workshop "Bioequivalence, Biopharmaceutics Classification System, and Beyond" was held May 21-23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics Classification System (BCS), bioequivalence of oral products, and related FDA initiatives such as the FDA Critical Path Initiative. The objective of this Summary Workshop Report is to document the main points from this workshop. Key highlights of the workshop were (a) the described granting of over a dozen BCS-based biowaivers by the FDA for Class I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS in pharmaceutical research and development, and (e) scientific progress in in vitro dissolution methods to predict dosage form performance.

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Typ av publikation: tidskriftsartikel (2)

Typ av innehåll: refereegranskat (2)

Författare/redaktör: Shah, Vinod P. (2); Fackler, Paul (2); Abrahamsson, Bertil (1); Zhang, Hua (1); Amidon, Gordon L. (1); Polli, James E. (1); visa fler...; Yu, Lawrence X. (1); Wu, Yunhui (1); Sun, Duxin (1); Chen, Mei-Ling (1); Ganes, Derek (1); Midha, Kamal K (1); Caro, James (1); Nambiar, Prabu (1); Rocci, Mario L (1); Thombre, Avinash G (1); Conner, Dale (1); Davit, Barbara (1); Farrell, Colm (1); Gupta, Suneel (1); Katz, Russell (1); Mehta, Mehul (1); Preskorn, Sheldon H (1); Sanderink, Gerard (1); Stavchansky, Salomon (1); Temple, Robert (1); Wang, Yaning (1); Winkle, Helen (1); Yu, Lawrence (1); Abrahamsson, Bertil ... (1); Baldoni, John M (1); Cook, Jack A (1); Hartauer, Kerry (1); Johnston, Gordon (1); Krill, Steve L (1); Lipper, Robert A (1); Malick, Waseem A (1); Winkle, Helen N (1); visa färre...

Lärosäte: Uppsala universitet (2)

Språk: Engelska (2)

Forskningsämne (UKÄ/SCB): Medicin och hälsovetenskap (2)

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