Literature DB >> 21491148

The BCS, BDDCS, and regulatory guidances.

Mei-Ling Chen1, Gordon L Amidon, Leslie Z Benet, Hans Lennernas, Lawrence X Yu.   

Abstract

Mesh:

Year:  2011        PMID: 21491148     DOI: 10.1007/s11095-011-0438-1

Source DB:  PubMed          Journal:  Pharm Res        ISSN: 0724-8741            Impact factor:   4.200


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  17 in total

1.  The "high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs.

Authors:  Mehran Yazdanian; Katherine Briggs; Corinne Jankovsky; Amale Hawi
Journal:  Pharm Res       Date:  2004-02       Impact factor: 4.200

Review 2.  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

Review 3.  The use of biopharmaceutic classification of drugs in drug discovery and development: current status and future extension.

Authors:  Hans Lennernäs; Bertil Abrahamsson
Journal:  J Pharm Pharmacol       Date:  2005-03       Impact factor: 3.765

4.  Systems chemical biology.

Authors:  Tudor I Oprea; Alexander Tropsha; Jean-Loup Faulon; Mark D Rintoul
Journal:  Nat Chem Biol       Date:  2007-08       Impact factor: 15.040

5.  The use of BDDCS in classifying the permeability of marketed drugs.

Authors:  Leslie Z Benet; Gordon L Amidon; Dirk M Barends; Hans Lennernäs; James E Polli; Vinod P Shah; Salomon A Stavchansky; Lawrence X Yu
Journal:  Pharm Res       Date:  2008-01-31       Impact factor: 4.200

6.  Computational models to assign biopharmaceutics drug disposition classification from molecular structure.

Authors:  Akash Khandelwal; Praveen M Bahadduri; Cheng Chang; James E Polli; Peter W Swaan; Sean Ekins
Journal:  Pharm Res       Date:  2007-09-11       Impact factor: 4.200

Review 7.  Computational systems chemical biology.

Authors:  Tudor I Oprea; Elebeoba E May; Andrei Leitão; Alexander Tropsha
Journal:  Methods Mol Biol       Date:  2011

8.  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

9.  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

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

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  20 in total

Review 1.  BDDCS Predictions, Self-Correcting Aspects of BDDCS Assignments, BDDCS Assignment Corrections, and Classification for more than 175 Additional Drugs.

Authors:  Chelsea M Hosey; Rosa Chan; Leslie Z Benet
Journal:  AAPS J       Date:  2015-11-20       Impact factor: 4.009

2.  Predicting Clearance Mechanism in Drug Discovery: Extended Clearance Classification System (ECCS).

Authors:  Manthena V Varma; Stefanus J Steyn; Charlotte Allerton; Ayman F El-Kattan
Journal:  Pharm Res       Date:  2015-07-09       Impact factor: 4.200

3.  BDDCS applied to over 900 drugs.

Authors:  Leslie Z Benet; Fabio Broccatelli; Tudor I Oprea
Journal:  AAPS J       Date:  2011-08-05       Impact factor: 4.009

4.  Predicting the extent of metabolism using in vitro permeability rate measurements and in silico permeability rate predictions.

Authors:  Chelsea M Hosey; Leslie Z Benet
Journal:  Mol Pharm       Date:  2015-04-23       Impact factor: 4.939

5.  Drug discovery and regulatory considerations for improving in silico and in vitro predictions that use Caco-2 as a surrogate for human intestinal permeability measurements.

Authors:  Caroline A Larregieu; Leslie Z Benet
Journal:  AAPS J       Date:  2013-01-24       Impact factor: 4.009

Review 6.  Drug Disposition Classification Systems in Discovery and Development: A Comparative Review of the BDDCS, ECCS and ECCCS Concepts.

Authors:  Gian P Camenisch
Journal:  Pharm Res       Date:  2016-07-20       Impact factor: 4.200

Review 7.  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

Review 8.  The role of BCS (biopharmaceutics classification system) and BDDCS (biopharmaceutics drug disposition classification system) in drug development.

Authors:  Leslie Z Benet
Journal:  J Pharm Sci       Date:  2012-11-12       Impact factor: 3.534

9.  Comparison of the permeability of metoprolol and labetalol in rat, mouse, and Caco-2 cells: use as a reference standard for BCS classification.

Authors:  Tuba Incecayir; Yasuhiro Tsume; Gordon L Amidon
Journal:  Mol Pharm       Date:  2013-02-04       Impact factor: 4.939

10.  Experimental and theoretical studies on the molecular properties of ciprofloxacin, norfloxacin, pefloxacin, sparfloxacin, and gatifloxacin in determining bioavailability.

Authors:  E Kłosińska-Szmurło; F A Pluciński; M Grudzień; K Betlejewska-Kielak; J Biernacka; A P Mazurek
Journal:  J Biol Phys       Date:  2014-07-18       Impact factor: 1.365

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