265 related articles for article (PubMed ID: 34019712)
1. In vitro and In silico biopharmaceutic regulatory guidelines for generic bioequivalence for oral products: Comparison among various regulatory agencies.
Kollipara S; Ahmed T; Bhattiprolu AK; Chachad S
Biopharm Drug Dispos; 2021 Jul; 42(7):297-318. PubMed ID: 34019712
[TBL] [Abstract][Full Text] [Related]
2. Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.
Mehta MU; Uppoor RS; Conner DP; Seo P; Vaidyanathan J; Volpe DA; Stier E; Chilukuri D; Dorantes A; Ghosh T; Mandula H; Raines K; Dhanormchitphong P; Woodcock J; Yu LX
Mol Pharm; 2017 Dec; 14(12):4334-4338. PubMed ID: 29076742
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. 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]
5. Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.
Sullivan JO; Blake K; Berntgen M; Salmonson T; Welink J;
Clin Pharmacol Ther; 2018 Sep; 104(3):539-545. PubMed ID: 29319156
[TBL] [Abstract][Full Text] [Related]
6. 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]
7. Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan.
Kuribayashi R; Takishita T; Mikami K
J Pharm Sci; 2016 Aug; 105(8):2270-7. PubMed ID: 27372551
[TBL] [Abstract][Full Text] [Related]
8. An overview of regulations for bioequivalence assessment of locally acting orally inhaled drug products for the United States, Europe, Canada, and India.
Patil PP; Pawar AP; Mahadik KR; Gaikwad VL
Expert Opin Drug Deliv; 2021 Dec; 18(12):1843-1855. PubMed ID: 34814778
[TBL] [Abstract][Full Text] [Related]
9. 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]
10. Application of physiologically based absorption and pharmacokinetic modeling in the development process of oral modified release generic products.
Subhani S; Kim C; Muniz P; Rodriguez M; van Os S; Suarez E; Cristofoletti R; Schmidt S; Vozmediano V
Eur J Pharm Biopharm; 2022 Jul; 176():87-94. PubMed ID: 35598768
[TBL] [Abstract][Full Text] [Related]
11. The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.
Chen ML; Blume H; Beuerle G; Davit B; Mehta M; Potthast H; Schug B; Tsang YC; Wedemeyer RS; Weitschies W; Welink J
Eur J Pharm Sci; 2018 Jan; 111():153-157. PubMed ID: 28964950
[TBL] [Abstract][Full Text] [Related]
12. Current Regulatory Standpoint on Evaluating the Bioequivalence of Different Classes of Generic Drugs - Is the Evaluation in the Right Direction?
Micheal F; Sayana M; Motial BM
Curr Drug Metab; 2019; 20(10):835-844. PubMed ID: 31589117
[TBL] [Abstract][Full Text] [Related]
13. A Novel Approach to Justify Dissolution Differences in an Extended Release Drug Product using Physiologically Based Biopharmaceutics Modeling and Simulation.
Aishwarya R; Murthy A; Ahmed T; Chachad S
J Pharm Sci; 2022 Jun; 111(6):1820-1832. PubMed ID: 35217007
[TBL] [Abstract][Full Text] [Related]
14. 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]
15. Scientific considerations to move towards biowaiver for biopharmaceutical classification system class III drugs: How modeling and simulation can help.
Wu F; Cristofoletti R; Zhao L; Rostami-Hodjegan A
Biopharm Drug Dispos; 2021 Apr; 42(4):118-127. PubMed ID: 33759204
[TBL] [Abstract][Full Text] [Related]
16. Variability and impact on design of bioequivalence studies.
Van Peer A
Basic Clin Pharmacol Toxicol; 2010 Mar; 106(3):146-53. PubMed ID: 20041877
[TBL] [Abstract][Full Text] [Related]
17. In Vitro Dissolution as a Tool for Formulation Selection: Telmisartan Two-Step IVIVC.
Ruiz Picazo A; Martinez-Martinez MT; Colón-Useche S; Iriarte R; Sánchez-Dengra B; González-Álvarez M; García-Arieta A; González-Álvarez I; Bermejo M
Mol Pharm; 2018 Jun; 15(6):2307-2315. PubMed ID: 29746133
[TBL] [Abstract][Full Text] [Related]
18. 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]
19. Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.
Chen ML; Shah VP; Crommelin DJ; Shargel L; Bashaw D; Bhatti M; Blume H; Dressman J; Ducharme M; Fackler P; Hyslop T; Lutter L; Morais J; Ormsby E; Thomas S; Tsang YC; Velagapudi R; Yu LX
Eur J Pharm Sci; 2011 Nov; 44(4):506-13. PubMed ID: 21946259
[TBL] [Abstract][Full Text] [Related]
20. Physiologically Based Pharmacokinetics Modeling in Biopharmaceutics: Case Studies for Establishing the Bioequivalence Safe Space for Innovator and Generic Drugs.
Wu D; Sanghavi M; Kollipara S; Ahmed T; Saini AK; Heimbach T
Pharm Res; 2023 Feb; 40(2):337-357. PubMed ID: 35840856
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
