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.
210 related articles for article (PubMed ID: 33247363)
1. Modernization and Strengthening of Bioequivalence Guidelines in Japan. Kuribayashi R; Yamaguchi T; Takagi K Clin Pharmacokinet; 2021 Feb; 60(2):145-151. PubMed ID: 33247363 [TBL] [Abstract][Full Text] [Related]
2. Current Regulation for Bioequivalence Evaluations of Generic Ophthalmic Dosage Forms in Japan. Myoenzono A; Kuribayashi R; Yamaguchi T; Ogawa T; Takagi K Eur J Drug Metab Pharmacokinet; 2020 Dec; 45(6):697-702. PubMed ID: 32930951 [TBL] [Abstract][Full Text] [Related]
3. 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]
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. Generic Drug Product Development in Japan: Regulatory Updates During 2014-2019 and the Future. Kasuga M; Kuribayashi R; Ogawa T; Ugi A; Yamaguchi T; Takagi K; Hirota M Eur J Drug Metab Pharmacokinet; 2021 Nov; 46(6):711-719. PubMed ID: 34586614 [TBL] [Abstract][Full Text] [Related]
6. [Trends in the quality evaluation of generic products and bioequivalence guidelines]. Yomota C Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 2012; (130):1-12. PubMed ID: 23243982 [TBL] [Abstract][Full Text] [Related]
7. First approval of generic dry powder inhaler drug products in Japan. Kuribayashi R; Myoenzono A Drug Deliv Transl Res; 2020 Oct; 10(5):1517-1519. PubMed ID: 32613551 [TBL] [Abstract][Full Text] [Related]
8. First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA. Kuribayashi R; Kasuga M; Kuwana K; Yamaguchi T Ther Innov Regul Sci; 2023 Mar; 57(2):173-177. PubMed ID: 36100793 [TBL] [Abstract][Full Text] [Related]
9. Current Understanding of the Equivalence Evaluations for In Vitro Tests on Generic Dry Powder Inhaler Drug Products in Japan. Kuribayashi R; Myoenzono A; Takagi K; Hirota M Eur J Drug Metab Pharmacokinet; 2019 Dec; 44(6):743-745. PubMed ID: 31062276 [TBL] [Abstract][Full Text] [Related]
10. Critical considerations into the new EMA guideline on bioequivalence. Marzo A; Fontana E Arzneimittelforschung; 2011; 61(4):207-20. PubMed ID: 21650079 [TBL] [Abstract][Full Text] [Related]
11. Comparison of Dissolution Similarity Assessment Methods for Products with Large Variations: f Yoshida H; Shibata H; Izutsu KI; Goda Y Biol Pharm Bull; 2017; 40(5):722-725. PubMed ID: 28458360 [TBL] [Abstract][Full Text] [Related]
12. Japanese regulation of biosimilar products: past experience and current challenges. Arato T Br J Clin Pharmacol; 2016 Jul; 82(1):30-40. PubMed ID: 26987746 [TBL] [Abstract][Full Text] [Related]
13. Global harmonization of immediate-release solid oral drug product bioequivalence recommendations and the impact on generic drug development. Kotsybar J; Hakeem S; Zhang L; Jiang W Clin Transl Sci; 2023 Dec; 16(12):2756-2764. PubMed ID: 37904315 [TBL] [Abstract][Full Text] [Related]
14. International harmonization of bioequivalence studies and issues shared in common. Nakai K; Fujita M; Ogata H Yakugaku Zasshi; 2000 Nov; 120(11):1193-200. PubMed ID: 11190204 [TBL] [Abstract][Full Text] [Related]
15. 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]
16. 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]
17. 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]
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. 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]
20. 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] [Next] [New Search]