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.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

171 related articles for article (PubMed ID: 34586614)

  • 1. 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]  

  • 2. 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]  

  • 3. 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]  

  • 4. 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]  

  • 5. 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]  

  • 6. 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]  

  • 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. Scientific and regulatory activities initiated by the U.S. Food and drug administration to foster approvals of generic dry powder inhalers: Bioequivalence perspective.
    Newman B; Babiskin A; Bielski E; Boc S; Dhapare S; Fang L; Feibus K; Kaviratna A; Li BV; Luke MC; Ma T; Spagnola M; Walenga RL; Wang Z; Zhao L; El-Gendy N; Bertha CM; Abd El-Shafy M; Gaglani DK
    Adv Drug Deliv Rev; 2022 Nov; 190():114526. PubMed ID: 36067967
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Scientific and regulatory activities initiated by the U.S. food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective.
    El-Gendy N; Bertha CM; Abd El-Shafy M; Gaglani DK; Babiskin A; Bielski E; Boc S; Dhapare S; Fang L; Feibus K; Kaviratna A; Li BV; Luke MC; Ma T; Newman B; Spagnola M; Walenga RL; Zhao L
    Adv Drug Deliv Rev; 2022 Oct; 189():114519. PubMed ID: 36038083
    [TBL] [Abstract][Full Text] [Related]  

  • 10. 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]  

  • 11. Regulation of Generic Drugs in Japan: the Current Situation and Future Prospects.
    Kuribayashi R; Matsuhama M; Mikami K
    AAPS J; 2015 Sep; 17(5):1312-6. PubMed ID: 25943503
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Batch-to-Batch and Within-Subject Variability: What Do We Know and How Do These Variabilities Affect Clinical Pharmacology and Bioequivalence?
    Benet LZ; Jayachandran P; Carroll KJ; Burmeister Getz E
    Clin Pharmacol Ther; 2019 Feb; 105(2):326-328. PubMed ID: 30652313
    [No Abstract]   [Full Text] [Related]  

  • 13. 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]  

  • 14. Current Japanese Regulatory Systems for Generics and Biosimilars.
    Kuribayashi R; Sawanobori K
    J Pharm Sci; 2018 Mar; 107(3):785-787. PubMed ID: 29113922
    [TBL] [Abstract][Full Text] [Related]  

  • 15. [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]  

  • 16. Generic drug device combination products: Regulatory and scientific considerations.
    Choi SH; Wang Y; Conti DS; Raney SG; Delvadia R; Leboeuf AA; Witzmann K
    Int J Pharm; 2018 Jun; 544(2):443-454. PubMed ID: 29170118
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Regulatory aspects of modifications to innovator bronchodilator metered dose inhalers and development of generic substitutes.
    Adams WP; Poochikian G; Taylor AS; Patel RM; Burke GP; Williams RL
    J Aerosol Med; 1994; 7(2):119-34. PubMed ID: 10147277
    [TBL] [Abstract][Full Text] [Related]  

  • 18. 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]  

  • 19. Dissolution testing for generic drugs: an FDA perspective.
    Anand O; Yu LX; Conner DP; Davit BM
    AAPS J; 2011 Sep; 13(3):328-35. PubMed ID: 21479700
    [TBL] [Abstract][Full Text] [Related]  

  • 20. An Update of the Brazilian Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products.
    Soares KC; Santos GM; Gelfuso GM; Gratieri T
    AAPS J; 2015 Nov; 17(6):1517-8. PubMed ID: 26122498
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.