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 *

180 related articles for article (PubMed ID: 35133652)

  • 1. Considerations for the Forced Expiratory Volume in 1 Second-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products.
    Lee J; Feng K; Conti DS; Walenga R; Wientjes M; Wang H; Newman B; Han L; Dhapare S; Bielski E; Babiskin A; Wu F; Donnelly M; Kim MJ; Jiang W; Luke MC; Fang L; Zhao L
    Clin Pharmacol Ther; 2022 Nov; 112(5):982-989. PubMed ID: 35133652
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Addressing the Regulatory and Scientific Challenges with Generic Orally Inhaled Drug Products.
    Newman B; Witzmann K
    Pharmaceut Med; 2020 Apr; 34(2):93-102. PubMed ID: 32112304
    [TBL] [Abstract][Full Text] [Related]  

  • 3. An overview of regulations for bioequivalence assessment of locally acting orally inhaled drug products for the United States, Europe, Canada, and India.
    Patil PP; Pawar AP; Mahadik KR; Gaikwad VL
    Expert Opin Drug Deliv; 2021 Dec; 18(12):1843-1855. PubMed ID: 34814778
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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]  

  • 5. 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]  

  • 6. Understanding the Essentialities in Establishing the Bioequivalence of Oral Inhalation Drug Products to be Marketed in the USA.
    Fernandes SD; Koland M
    Ther Innov Regul Sci; 2020 Jul; 54(4):738-748. PubMed ID: 32557296
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Scientific Considerations for the Review and Approval of First Generic Mometasone Furoate Nasal Suspension Spray in the United States from the Bioequivalence Perspective.
    Liu Q; Absar M; Saluja B; Guo C; Chowdhury B; Lionberger R; Conner DP; Li BV
    AAPS J; 2019 Jan; 21(2):14. PubMed ID: 30617594
    [TBL] [Abstract][Full Text] [Related]  

  • 8. 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]  

  • 9. Leveraging Modeling and Simulation to Enhance the Efficiency of Bioequivalence Approaches for Generic Drugs: Highlights from the 2023 Generic Drug Science and Research Initiatives Public Workshop.
    Pal A; Wu F; Walenga R; Tsakalozou E; Alam K; Gong Y; Zhao L; Fang L
    AAPS J; 2024 Apr; 26(3):45. PubMed ID: 38589695
    [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. A European perspective on orally inhaled products: in vitro requirements for a biowaiver.
    García-Arieta A
    J Aerosol Med Pulm Drug Deliv; 2014 Dec; 27(6):419-29. PubMed ID: 25238116
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug Administration.
    Davit BM; Chen ML; Conner DP; Haidar SH; Kim S; Lee CH; Lionberger RA; Makhlouf FT; Nwakama PE; Patel DT; Schuirmann DJ; Yu LX
    AAPS J; 2012 Dec; 14(4):915-24. PubMed ID: 22972221
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products.
    Choi SH; Lionberger RA
    AAPS J; 2016 Jul; 18(4):1032-8. PubMed ID: 27184578
    [TBL] [Abstract][Full Text] [Related]  

  • 14. 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]  

  • 15. Quantitative assessment of the switchability of generic products.
    Karalis V; Bialer M; Macheras P
    Eur J Pharm Sci; 2013 Nov; 50(3-4):476-83. PubMed ID: 23981332
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference.
    Hochhaus G; Davis-Cutting C; Oliver M; Lee SL; Lyapustina S
    AAPS J; 2015 Sep; 17(5):1305-11. PubMed ID: 26033698
    [TBL] [Abstract][Full Text] [Related]  

  • 17. 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]  

  • 18. Classification of torasemide based on the Biopharmaceutics Classification System and evaluation of the FDA biowaiver provision for generic products of CLASS I drugs.
    Khan MZ; Rausl D; Radosević S; Filić D; Danilovski A; Dumić M; Knezević Z
    J Pharm Pharmacol; 2006 Nov; 58(11):1475-82. PubMed ID: 17132210
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development.
    Gong Y; Barretto FX; Tsong Y; Mousa Y; Ren K; Kozak D; Shen M; Hu M; Zhao L
    AAPS J; 2024 Jan; 26(1):15. PubMed ID: 38267593
    [TBL] [Abstract][Full Text] [Related]  

  • 20. 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]  

    [Next]    [New Search]
    of 9.