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 *

204 related articles for article (PubMed ID: 32930951)

  • 21. Quality and equivalence of topical products: A critical appraisal.
    Miranda M; Cardoso C; Vitorino C
    Eur J Pharm Sci; 2020 May; 148():105082. PubMed ID: 31626969
    [TBL] [Abstract][Full Text] [Related]  

  • 22. 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]  

  • 23. Japanese guidance on bioavailability and bioequivalence.
    Aoyagi N
    Eur J Drug Metab Pharmacokinet; 2000; 25(1):28-31. PubMed ID: 11032086
    [TBL] [Abstract][Full Text] [Related]  

  • 24. Some thoughts on drug interchangeability.
    Chow SC; Song F; Chen M
    J Biopharm Stat; 2016; 26(1):178-86. PubMed ID: 26366703
    [TBL] [Abstract][Full Text] [Related]  

  • 25. 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]  

  • 26. 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]  

  • 27. Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.
    Kesselheim AS; Polinski JM; Fulchino LA; Isaman DL; Gagne JJ
    Drugs; 2015 Apr; 75(6):633-50. PubMed ID: 25822610
    [TBL] [Abstract][Full Text] [Related]  

  • 28. 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]  

  • 29. 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]  

  • 30. 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]  

  • 31. Bioequivalence study designs for generic solid oral anticancer drug products: scientific and regulatory considerations.
    Kaur P; Chaurasia CS; Davit BM; Conner DP
    J Clin Pharmacol; 2013 Dec; 53(12):1252-60. PubMed ID: 23996908
    [TBL] [Abstract][Full Text] [Related]  

  • 32. Bioequivalence and other unresolved issues in generic drug substitution.
    Meredith P
    Clin Ther; 2003 Nov; 25(11):2875-90. PubMed ID: 14693311
    [TBL] [Abstract][Full Text] [Related]  

  • 33. 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]  

  • 34. Is Bioequivalence a Sufficient Measure of Equivalence?
    Holman A
    J Leg Med; 2019; 39(3):247-261. PubMed ID: 31626574
    [TBL] [Abstract][Full Text] [Related]  

  • 35. 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]  

  • 36. Bioequivalence of topical generic products. Part 2. Paving the way to a tailored regulatory system.
    Miranda M; Sousa JJ; Veiga F; Cardoso C; Vitorino C
    Eur J Pharm Sci; 2018 Sep; 122():264-272. PubMed ID: 29981406
    [TBL] [Abstract][Full Text] [Related]  

  • 37. 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]  

  • 38. Bioequivalence of topical generic products. Part 1: Where are we now?
    Miranda M; Sousa JJ; Veiga F; Cardoso C; Vitorino C
    Eur J Pharm Sci; 2018 Oct; 123():260-267. PubMed ID: 30053463
    [TBL] [Abstract][Full Text] [Related]  

  • 39. 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]  

  • 40. 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]  

    [Previous]   [Next]    [New Search]
    of 11.