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Literature DB >> 21775984

Bioequivalence of oral products and the biopharmaceutics classification system: science, regulation, and public policy.

K S Amidon¹, P Langguth, H Lennernäs, L Yu, G L Amidon.

Abstract

Entities: CellLine Chemical Disease Gene Species

Mesh：

Substances：

Year: 2011 PMID： 21775984 PMCID： PMC3228645 DOI： 10.1038/clpt.2011.109

Source DB: PubMed Journal: Clin Pharmacol Ther ISSN： 0009-9236 Impact factor: 6.875

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18 in total

Review 1. Bioavailability and bioequivalence: an FDA regulatory overview.

Authors: M L Chen; V Shah; R Patnaik; W Adams; A Hussain; D Conner; M Mehta; H Malinowski; J Lazor; S M Huang; D Hare; L Lesko; D Sporn; R Williams
Journal: Pharm Res Date: 2001-12 Impact factor: 4.200

2. Comparison of human duodenum and Caco-2 gene expression profiles for 12,000 gene sequences tags and correlation with permeability of 26 drugs.

Authors: Duxin Sun; Hans Lennernas; Lynda S Welage; Jeffery L Barnett; Christopher P Landowski; David Foster; David Fleisher; Kyung-Dall Lee; Gordon L Amidon
Journal: Pharm Res Date: 2002-10 Impact factor: 4.200

Review 3. Predicting drug disposition via application of BCS: transport/absorption/ elimination interplay and development of a biopharmaceutics drug disposition classification system.

Authors: Chi-Yuan Wu; Leslie Z Benet
Journal: Pharm Res Date: 2005-01 Impact factor: 4.200

4. Drug bioequivalence. Recommendations from the Drug Bioequivalence Study Panel to the Office of Technology Assessment, Congress of the United States.

Authors:
Journal: J Pharmacokinet Biopharm Date: 1974-10

5. White paper on the therapeutic equivalence of chemically equivalent drugs.

Authors: W B Castle; E B Astwood; M Finland; C S Keefer
Journal: JAMA Date: 1969-05-19 Impact factor: 56.272

6. A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain, and Japan.

Authors: Toshihide Takagi; Chandrasekharan Ramachandran; Marival Bermejo; Shinji Yamashita; Lawrence X Yu; Gordon L Amidon
Journal: Mol Pharm Date: 2006 Nov-Dec Impact factor: 4.939

7. High-permeability criterion for BCS classification: segmental/pH dependent permeability considerations.

Authors: Arik Dahan; Jonathan M Miller; John M Hilfinger; Shinji Yamashita; Lawrence X Yu; Hans Lennernäs; Gordon L Amidon
Journal: Mol Pharm Date: 2010-09-03 Impact factor: 4.939

8. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability.

Authors: G L Amidon; H Lennernäs; V P Shah; J R Crison
Journal: Pharm Res Date: 1995-03 Impact factor: 4.200

Review 9. What is the objective of the mass balance study? A retrospective analysis of data in animal and human excretion studies employing radiolabeled drugs.

Authors: Sarah J Roffey; R Scott Obach; Jenny I Gedge; Dennis A Smith
Journal: Drug Metab Rev Date: 2007 Impact factor: 4.518

10. Biopharmaceutics classification of selected beta-blockers: solubility and permeability class membership.

Authors: Yongsheng Yang; Patrick J Faustino; Donna A Volpe; Christopher D Ellison; Robbe C Lyon; Lawrence X Yu
Journal: Mol Pharm Date: 2007-07-18 Impact factor: 4.939

10 in total

Review 1. Implementing the Biopharmaceutics Classification System in Drug Development: Reconciling Similarities, Differences, and Shared Challenges in the EMA and US-FDA-Recommended Approaches.

Authors: J-M Cardot; A Garcia Arieta; P Paixao; I Tasevska; B Davit
Journal: AAPS J Date: 2016-04-26 Impact factor: 4.009

Review 2. BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements.

Authors: Barbara M Davit; Isadore Kanfer; Yu Chung Tsang; Jean-Michel Cardot
Journal: AAPS J Date: 2016-03-04 Impact factor: 4.009

3. The Biopharmaceutics Classification System: subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC.

Authors: Yasuhiro Tsume; Deanna M Mudie; Peter Langguth; Greg E Amidon; Gordon L Amidon
Journal: Eur J Pharm Sci Date: 2014-01-28 Impact factor: 4.384

4. The fraction dose absorbed, in humans, and high jejunal human permeability relationship.

Authors: Arik Dahan; Hans Lennernäs; Gordon L Amidon
Journal: Mol Pharm Date: 2012-05-04 Impact factor: 4.939

5. Regional-dependent intestinal permeability and BCS classification: elucidation of pH-related complexity in rats using pseudoephedrine.

Authors: Moran Fairstein; Rotem Swissa; Arik Dahan
Journal: AAPS J Date: 2013-02-26 Impact factor: 4.009