314 related articles for article (PubMed ID: 20635193)
1. From drug delivery systems to drug release, dissolution, IVIVC, BCS, BDDCS, bioequivalence and biowaivers.
Karalis V; Magklara E; Shah VP; Macheras P
Pharm Res; 2010 Sep; 27(9):2018-29. PubMed ID: 20635193
[TBL] [Abstract][Full Text] [Related]
2. A perspective for biowaivers of human bioequivalence studies on the basis of the combination of the ratio of AUC to the dose and the biopharmaceutics classification system.
Sakuma S; Tachiki H; Uchiyama H; Fukui Y; Takeuchi N; Kumamoto K; Satoh T; Yamamoto Y; Ishii E; Sakai Y; Takeuchi S; Sugita M; Yamashita S
Mol Pharm; 2011 Aug; 8(4):1113-9. PubMed ID: 21630662
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. The Biopharmaceutics Classification System: subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC.
Tsume Y; Mudie DM; Langguth P; Amidon GE; Amidon GL
Eur J Pharm Sci; 2014 Jun; 57():152-63. PubMed ID: 24486482
[TBL] [Abstract][Full Text] [Related]
5. In vitro - in vivo correlation: from theory to applications.
Emami J
J Pharm Pharm Sci; 2006; 9(2):169-89. PubMed ID: 16959187
[TBL] [Abstract][Full Text] [Related]
6. Bioavailability and bioequivalence: focus on physiological factors and variability.
Karalis V; Macheras P; Van Peer A; Shah VP
Pharm Res; 2008 Aug; 25(8):1956-62. PubMed ID: 18551249
[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. 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]
9. 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]
10. Oral biopharmaceutics tools - time for a new initiative - an introduction to the IMI project OrBiTo.
Lennernäs H; Aarons L; Augustijns P; Beato S; Bolger M; Box K; Brewster M; Butler J; Dressman J; Holm R; Julia Frank K; Kendall R; Langguth P; Sydor J; Lindahl A; McAllister M; Muenster U; Müllertz A; Ojala K; Pepin X; Reppas C; Rostami-Hodjegan A; Verwei M; Weitschies W; Wilson C; Karlsson C; Abrahamsson B
Eur J Pharm Sci; 2014 Jun; 57():292-9. PubMed ID: 24189462
[TBL] [Abstract][Full Text] [Related]
11. Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies.
Kajiwara E; Kamizato H; Shikano M
Ther Innov Regul Sci; 2021 Sep; 55(5):1096-1100. PubMed ID: 34097289
[TBL] [Abstract][Full Text] [Related]
12. Impact of Biopharmaceutics Classification System-based biowaivers.
Cook JA; Davit BM; Polli JE
Mol Pharm; 2010 Oct; 7(5):1539-44. PubMed ID: 20735084
[TBL] [Abstract][Full Text] [Related]
13. The Gradually Expanding Scope for Biowaivers of Oral Products: An Overview.
Saluja V; Singh A; Algradi AM
Curr Pharm Des; 2016; 22(42):6434-6443. PubMed ID: 27396596
[TBL] [Abstract][Full Text] [Related]
14. Very rapid dissolution is not needed to guarantee bioequivalence for biopharmaceutics classification system (BCS) I drugs.
Kortejärvi H; Shawahna R; Koski A; Malkki J; Ojala K; Yliperttula M
J Pharm Sci; 2010 Feb; 99(2):621-5. PubMed ID: 19844950
[TBL] [Abstract][Full Text] [Related]
15. Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond.
Polli JE; Abrahamsson BS; Yu LX; Amidon GL; Baldoni JM; Cook JA; Fackler P; Hartauer K; Johnston G; Krill SL; Lipper RA; Malick WA; Shah VP; Sun D; Winkle HN; Wu Y; Zhang H
AAPS J; 2008 Jun; 10(2):373-9. PubMed ID: 18679807
[TBL] [Abstract][Full Text] [Related]
16. Keeping a critical eye on the science and the regulation of oral drug absorption: a review.
Macheras P; Karalis V; Valsami G
J Pharm Sci; 2013 Sep; 102(9):3018-36. PubMed ID: 23568812
[TBL] [Abstract][Full Text] [Related]
17. Scientific considerations concerning the EMA change in the definition of "dose" of the BCS-based biowaiver guideline and implications for bioequivalence.
Daousani C; Macheras P
Int J Pharm; 2015 Jan; 478(2):606-9. PubMed ID: 25437115
[TBL] [Abstract][Full Text] [Related]
18. In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context.
Lennernäs H; Lindahl A; Van Peer A; Ollier C; Flanagan T; Lionberger R; Nordmark A; Yamashita S; Yu L; Amidon GL; Fischer V; Sjögren E; Zane P; McAllister M; Abrahamsson B
Mol Pharm; 2017 Apr; 14(4):1307-1314. PubMed ID: 28195732
[TBL] [Abstract][Full Text] [Related]
19. 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]
20. Predicting Pharmacokinetics of Multisource Acyclovir Oral Products Through Physiologically Based Biopharmaceutics Modeling.
García MA; Bolger MB; Suarez-Sharp S; Langguth P
J Pharm Sci; 2022 Jan; 111(1):262-273. PubMed ID: 34678271
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]