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.
270 related articles for article (PubMed ID: 23821352)
1. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences. Davit B; Braddy AC; Conner DP; Yu LX AAPS J; 2013 Oct; 15(4):974-90. PubMed ID: 23821352 [TBL] [Abstract][Full Text] [Related]
2. Survey of international regulatory bioequivalence recommendations for approval of generic topical dermatological drug products. Braddy AC; Davit BM; Stier EM; Conner DP AAPS J; 2015 Jan; 17(1):121-33. PubMed ID: 25344440 [TBL] [Abstract][Full Text] [Related]
3. Similarities and differences of international guidelines for bioequivalence: an update of the Brazilian requirements. Rediguieri CF; Cristofoletti R; Soares KC; Tavares-Neto J AAPS J; 2014 Mar; 16(2):350-1. PubMed ID: 24493374 [No Abstract] [Full Text] [Related]
4. International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences. Lu D; Lee SL; Lionberger RA; Choi S; Adams W; Caramenico HN; Chowdhury BA; Conner DP; Katial R; Limb S; Peters JR; Yu L; Seymour S; Li BV AAPS J; 2015 May; 17(3):546-57. PubMed ID: 25758352 [TBL] [Abstract][Full Text] [Related]
5. 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]
6. A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme. Garcia Arieta A; Simon C; Lima Santos GM; Calderón Lojero IO; Rodríguez Martínez Z; Rodrigues C; Park SA; Kim JM; Kuribayashi R; Okada Y; Nolting A; Pfäffli C; Hung WY; Crane C; Braddy AC; Van Oudtshoorn J; Gutierrez Triana D; Clarke M J Pharm Pharm Sci; 2019; 22(1):28-36. PubMed ID: 30599818 [TBL] [Abstract][Full Text] [Related]
7. Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union. Kuribayashi R; Yamaguchi T; Sako H; Takishita T; Takagi K Clin Pharmacokinet; 2017 Mar; 56(3):225-233. PubMed ID: 27461251 [TBL] [Abstract][Full Text] [Related]
8. 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]
9. Bioequivalence studies for levothyroxine. Bolton S AAPS J; 2005 Mar; 7(1):E47-53. PubMed ID: 16146349 [TBL] [Abstract][Full Text] [Related]
10. A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme. Garcia Arieta A; Simon C; Tam A; Mendes Lima Santos G; Freitas Fernandes EA; Rodríguez Martínez Z; Rodrigues C; Park SA; Kim J; Kim K; Kuribayashi R; Myoenzono A; Shimojo K; Walther C; Roost MS; Hung WY; Hsu LF; Crane C; Braddy AC; Van Oudtshoorn J; Gutierrez Triana DA; Guzmán Aurela E; Jones B; Potthast H; Abalos I J Pharm Pharm Sci; 2021; 24():113-126. PubMed ID: 33734975 [TBL] [Abstract][Full Text] [Related]
11. Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities. Roost MS; Potthast H; Walther C; García-Arieta A; Abalos I; Agostinho Freitas Fernandes E; Mendes Lima Santos G; Rodríguez Martínez Z; Tam A; Rodrigues C; Gutierrez Triana DA; Guzmán Aurela E; Rodríguez Rodríguez N; Aeh Park S; Kim J; Kariv R; Divinsky M; Jones B; Kuribayashi R; Myoenzono A; Kasuga M; Van Oudtshoorn J; Chi JF; Hung WY; Hsu LF; Crane C; Jarman T; Braddy A J Pharm Pharm Sci; 2021; 24():548-562. PubMed ID: 34706215 [TBL] [Abstract][Full Text] [Related]
12. 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]
13. Comparison of Generic Drug Reviews for Marketing Authorization between Japan and Canada. Kuribayashi R; Appleton S Drugs R D; 2017 Sep; 17(3):371-379. PubMed ID: 28577294 [TBL] [Abstract][Full Text] [Related]
14. Bioequivalence of oral products and the biopharmaceutics classification system: science, regulation, and public policy. Amidon KS; Langguth P; Lennernäs H; Yu L; Amidon GL Clin Pharmacol Ther; 2011 Sep; 90(3):467-70. PubMed ID: 21775984 [TBL] [Abstract][Full Text] [Related]
15. International veterinary bioequivalence guideline similarities and differences between Australia, Canada, Europe, Japan, New Zealand and the United States. Lainesse C AAPS J; 2012 Dec; 14(4):792-8. PubMed ID: 22864669 [TBL] [Abstract][Full Text] [Related]
16. Current methodology to assess bioequivalence of levothyroxine sodium products is inadequate. Blakesley VA AAPS J; 2005 Mar; 7(1):E42-6. PubMed ID: 16146348 [TBL] [Abstract][Full Text] [Related]
17. Quantitative assessment of the switchability of generic products. Karalis V; Bialer M; Macheras P Eur J Pharm Sci; 2013 Nov; 50(3-4):476-83. PubMed ID: 23981332 [TBL] [Abstract][Full Text] [Related]
18. Current regulatory approaches of bioequivalence testing. Karalis V; Macheras P Expert Opin Drug Metab Toxicol; 2012 Aug; 8(8):929-42. PubMed ID: 22681436 [TBL] [Abstract][Full Text] [Related]
19. Interchangeability between Generic and Reference Products: Limits of Average Bioequivalence Methodology. Lechat P Eur J Drug Metab Pharmacokinet; 2022 Nov; 47(6):777-787. PubMed ID: 35986193 [TBL] [Abstract][Full Text] [Related]
20. 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] [Next] [New Search]