These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
4. The use of biopharmaceutic classification of drugs in drug discovery and development: current status and future extension. Lennernäs H; Abrahamsson B J Pharm Pharmacol; 2005 Mar; 57(3):273-85. PubMed ID: 15807982 [TBL] [Abstract][Full Text] [Related]
5. The Discriminatory Power of the BCS-Based Biowaiver: A Retrospective With Focus on Essential Medicines. Hofsäss MA; Dressman JB J Pharm Sci; 2019 Sep; 108(9):2824-2837. PubMed ID: 31059698 [TBL] [Abstract][Full Text] [Related]
6. BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements. Davit BM; Kanfer I; Tsang YC; Cardot JM AAPS J; 2016 May; 18(3):612-8. PubMed ID: 26943914 [TBL] [Abstract][Full Text] [Related]
7. Feasibility of biowaiver extension to biopharmaceutics classification system class III drug products: cimetidine. Jantratid E; Prakongpan S; Amidon GL; Dressman JB Clin Pharmacokinet; 2006; 45(4):385-99. PubMed ID: 16584285 [TBL] [Abstract][Full Text] [Related]
8. G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability, Pharm Res 12, 413-420, 1995--backstory of BCS. Shah VP; Amidon GL AAPS J; 2014 Sep; 16(5):894-8. PubMed ID: 24961917 [TBL] [Abstract][Full Text] [Related]
9. The biopharmaceutics classification system (BCS): class III drugs - better candidates for BA/BE waiver? Blume HH; Schug BS Eur J Pharm Sci; 1999 Dec; 9(2):117-21. PubMed ID: 10620723 [TBL] [Abstract][Full Text] [Related]
10. The FDA should eliminate the ambiguities in the current BCS biowaiver guidance and make public the drugs for which BCS biowaivers have been granted. Benet LZ; Larregieu CA Clin Pharmacol Ther; 2010 Sep; 88(3):405-7. PubMed ID: 20668447 [TBL] [Abstract][Full Text] [Related]
11. [Biopharmaceutical classification system--experimental model of the prediction of drug bioavailability]. Golovenko NIa; Borisiuk IIu Biomed Khim; 2008; 54(4):392-407. PubMed ID: 18988456 [TBL] [Abstract][Full Text] [Related]
12. A comparative analysis of biopharmaceutics classification system and biopharmaceutics drug disposition classification system: a cross-sectional survey with 500 bioequivalence studies. Cristofoletti R; Chiann C; Dressman JB; Storpirtis S J Pharm Sci; 2013 Sep; 102(9):3136-44. PubMed ID: 23580377 [TBL] [Abstract][Full Text] [Related]
13. The Biopharmaceutics Classification System (BCS) and the Biopharmaceutics Drug Disposition Classification System (BDDCS): Beyond guidelines. Charalabidis A; Sfouni M; Bergström C; Macheras P Int J Pharm; 2019 Jul; 566():264-281. PubMed ID: 31108154 [TBL] [Abstract][Full Text] [Related]
14. Use of the Biopharmaceutical Classification System in early drug development. Ku MS AAPS J; 2008; 10(1):208-12. PubMed ID: 18446521 [TBL] [Abstract][Full Text] [Related]
15. Biopharmaceutics classification system-based biowaivers for generic oncology drug products: case studies. Tampal N; Mandula H; Zhang H; Li BV; Nguyen H; Conner DP AAPS PharmSciTech; 2015 Feb; 16(1):5-9. PubMed ID: 25245330 [TBL] [Abstract][Full Text] [Related]
16. Classification of torasemide based on the Biopharmaceutics Classification System and evaluation of the FDA biowaiver provision for generic products of CLASS I drugs. Khan MZ; Rausl D; Radosević S; Filić D; Danilovski A; Dumić M; Knezević Z J Pharm Pharmacol; 2006 Nov; 58(11):1475-82. PubMed ID: 17132210 [TBL] [Abstract][Full Text] [Related]
17. Biopharmaceutics classification system: the scientific basis for biowaiver extensions. Yu LX; Amidon GL; Polli JE; Zhao H; Mehta MU; Conner DP; Shah VP; Lesko LJ; Chen ML; Lee VH; Hussain AS Pharm Res; 2002 Jul; 19(7):921-5. PubMed ID: 12180542 [TBL] [Abstract][Full Text] [Related]
18. Application of the biopharmaceutical classification system in clinical drug development--an industrial view. Cook J; Addicks W; Wu YH AAPS J; 2008 Jun; 10(2):306-10. PubMed ID: 18500563 [TBL] [Abstract][Full Text] [Related]
19. Prediction of solubility and permeability class membership: provisional BCS classification of the world's top oral drugs. Dahan A; Miller JM; Amidon GL AAPS J; 2009 Dec; 11(4):740-6. PubMed ID: 19876745 [TBL] [Abstract][Full Text] [Related]
20. Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays. Miranda-Pérez de Alejo C; Aceituno Álvarez A; Mendes Lima Santos G; Fernández Cervera M; Jung-Cook H; Cabrera-Pérez MÁ Ther Innov Regul Sci; 2021 Jan; 55(1):65-81. PubMed ID: 32602028 [TBL] [Abstract][Full Text] [Related] [Next] [New Search]