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]