435 related articles for article (PubMed ID: 28004346)
1. Bioavailability and Bioequivalence Aspects of Oral Modified-Release Drug Products.
Wang R; Conner DP; Li BV
AAPS J; 2017 Mar; 19(2):360-366. PubMed ID: 28004346
[TBL] [Abstract][Full Text] [Related]
2. Modeling and simulation of biopharmaceutical performance.
Zhang X; Lionberger RA
Clin Pharmacol Ther; 2014 May; 95(5):480-2. PubMed ID: 24747237
[TBL] [Abstract][Full Text] [Related]
3. Physiologically Based Pharmacokinetic Modeling to Evaluate Formulation Factors Influencing Bioequivalence of Metoprolol Extended-Release Products.
Basu S; Yang H; Fang L; Gonzalez-Sales M; Zhao L; Trame MN; Lesko L; Schmidt S
J Clin Pharmacol; 2019 Sep; 59(9):1252-1263. PubMed ID: 31087553
[TBL] [Abstract][Full Text] [Related]
4. 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]
5. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration.
Davit BM; Nwakama PE; Buehler GJ; Conner DP; Haidar SH; Patel DT; Yang Y; Yu LX; Woodcock J
Ann Pharmacother; 2009 Oct; 43(10):1583-97. PubMed ID: 19776300
[TBL] [Abstract][Full Text] [Related]
6. Generic products of antiepileptic drugs: a perspective on bioequivalence, bioavailability, and formulation switches using Monte Carlo simulations.
Karalis V; Macheras P; Bialer M
CNS Drugs; 2014 Jan; 28(1):69-77. PubMed ID: 24092569
[TBL] [Abstract][Full Text] [Related]
7. Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report.
Chen ML; Shah VP; Ganes D; Midha KK; Caro J; Nambiar P; Rocci ML; Thombre AG; Abrahamsson B; Conner D; Davit B; Fackler P; Farrell C; Gupta S; Katz R; Mehta M; Preskorn SH; Sanderink G; Stavchansky S; Temple R; Wang Y; Winkle H; Yu L
Eur J Pharm Sci; 2010 May; 40(2):148-53. PubMed ID: 20347972
[TBL] [Abstract][Full Text] [Related]
8. Assessing bioequivalence of generic modified-release antiepileptic drugs.
Johnson EL; Chang YT; Davit B; Gidal BE; Krauss GL
Neurology; 2016 Apr; 86(17):1597-604. PubMed ID: 27016518
[TBL] [Abstract][Full Text] [Related]
9. Selection of oral controlled-release drugs: a critical decision for the physician.
Arnold RJ; Kaniecki DJ
South Med J; 1993 Feb; 86(2):208-14. PubMed ID: 8434294
[TBL] [Abstract][Full Text] [Related]
10. Dissolution Failure of Solid Oral Drug Products in Field Alert Reports.
Sun D; Hu M; Browning M; Friedman RL; Jiang W; Zhao L; Wen H
J Pharm Sci; 2017 May; 106(5):1302-1309. PubMed ID: 28104414
[TBL] [Abstract][Full Text] [Related]
11. Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products.
Choi SH; Lionberger RA
AAPS J; 2016 Jul; 18(4):1032-8. PubMed ID: 27184578
[TBL] [Abstract][Full Text] [Related]
12. Pharmaceutical equivalence by design for generic drugs: modified-release products.
Raw AS; Lionberger R; Yu LX
Pharm Res; 2011 Jul; 28(7):1445-53. PubMed ID: 21387150
[TBL] [Abstract][Full Text] [Related]
13. [Bioequivalence studies of pharmaceutical preparations].
Vetchý D; Frýbortová K; Rabisková M; Danecková H
Cas Lek Cesk; 2007; 146(5):431-3. PubMed ID: 17554963
[TBL] [Abstract][Full Text] [Related]
14. Oral Modified Drug Release Solid Dosage Form with Special Reference to Design; An Overview.
Murugesan S; Gowramma B; Lakshmanan K; Reddy Karri VVS; Radhakrishnan A
Curr Drug Res Rev; 2020; 12(1):16-25. PubMed ID: 31755398
[TBL] [Abstract][Full Text] [Related]
15. Influence of Drug Properties and Formulation on In Vitro Drug Release and Biowaiver Regulation of Oral Extended Release Dosage Forms.
Lin Z; Zhou D; Hoag S; Qiu Y
AAPS J; 2016 Mar; 18(2):333-45. PubMed ID: 26769249
[TBL] [Abstract][Full Text] [Related]
16. Application of Physiologically Based Absorption Modeling for Amphetamine Salts Drug Products in Generic Drug Evaluation.
Babiskin AH; Zhang X
J Pharm Sci; 2015 Sep; 104(9):3170-82. PubMed ID: 25973928
[TBL] [Abstract][Full Text] [Related]
17. A New Level A Type IVIVC for the Rational Design of Clinical Trials Toward Regulatory Approval of Generic Polymeric Long-Acting Injectables.
Somayaji MR; Das D; Przekwas A
Clin Pharmacokinet; 2016 Oct; 55(10):1179-1190. PubMed ID: 27349905
[TBL] [Abstract][Full Text] [Related]
18. FDA mulls changes to bioequivalence standards.
Traynor K
Am J Health Syst Pharm; 2010 Jun; 67(11):864. PubMed ID: 20484205
[No Abstract] [Full Text] [Related]
19. Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs.
Seoane-Vazquez E; Rodriguez-Monguio R; Hansen R
Clin Drug Investig; 2016 Apr; 36(4):281-92. PubMed ID: 26818406
[TBL] [Abstract][Full Text] [Related]
20. Investigation on the need of multiple dose bioequivalence studies for prolonged-release generic products.
García-Arieta A; Morales-Alcelay S; Herranz M; de la Torre-Alvarado JM; Blázquez-Pérez A; Suárez-Gea ML; Alvarez C
Int J Pharm; 2012 Feb; 423(2):321-5. PubMed ID: 22120644
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
