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 *

178 related articles for article (PubMed ID: 28577294)

  • 1. 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]  

  • 2. 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]  

  • 3. 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]  

  • 4. 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]  

  • 5. 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]  

  • 6. 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]  

  • 7. 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]  

  • 8. United States Food and Drug Administration requirements for approval of generic drug products.
    Meyer MC
    J Clin Psychiatry; 2001; 62 Suppl 5():4-9; discussion 23-4. PubMed ID: 11305846
    [TBL] [Abstract][Full Text] [Related]  

  • 9. 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]  

  • 10. Regulatory Approaches and Considerations in Establishing Bioequivalence of Inhaled Compounds.
    Mayers I; Bhutani M
    J Aerosol Med Pulm Drug Deliv; 2018 Feb; 31(1):18-24. PubMed ID: 28708443
    [TBL] [Abstract][Full Text] [Related]  

  • 11. 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]  

  • 12. Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.
    Sullivan JO; Blake K; Berntgen M; Salmonson T; Welink J;
    Clin Pharmacol Ther; 2018 Sep; 104(3):539-545. PubMed ID: 29319156
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India.
    Lee SL; Saluja B; García-Arieta A; Santos GM; Li Y; Lu S; Hou S; Rebello J; Vaidya A; Gogtay J; Purandare S; Lyapustina S
    AAPS J; 2015 Sep; 17(5):1285-304. PubMed ID: 26002510
    [TBL] [Abstract][Full Text] [Related]  

  • 14. A Systematic Review of Physicians' and Pharmacists' Perspectives on Generic Drug Use: What are the Global Challenges?
    Toverud EL; Hartmann K; Håkonsen H
    Appl Health Econ Health Policy; 2015 Aug; 13 Suppl 1(Suppl 1):S35-45. PubMed ID: 25963230
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Lawsuits anticipated on generic biologicals front.
    Fox JL
    Nat Biotechnol; 2003 Jul; 21(7):721-2. PubMed ID: 12833078
    [No Abstract]   [Full Text] [Related]  

  • 16. Acceptability of generic versus innovator oral medicines: not only a matter of taste.
    Tuleu C; Hughes DA; Clapham D; Vallet T; Ruiz F
    Drug Discov Today; 2021 Feb; 26(2):329-343. PubMed ID: 33217597
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Generating Model Integrated Evidence for Generic Drug Development and Assessment.
    Zhao L; Kim MJ; Zhang L; Lionberger R
    Clin Pharmacol Ther; 2019 Feb; 105(2):338-349. PubMed ID: 30414386
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Initial steps in the regulation of generic biological drugs: a comparison of U.S. and Canadian regimes.
    Szeto KJ; Wolanski M
    Food Drug Law J; 2012; 67(2):131-41, i. PubMed ID: 24620416
    [TBL] [Abstract][Full Text] [Related]  

  • 19. 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]  

  • 20. 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]  

    [Next]    [New Search]
    of 9.