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 *

167 related articles for article (PubMed ID: 22413806)

  • 1. Equivalence considerations for orally inhaled products for local action-ISAM/IPAC-RS European Workshop report.
    Evans C; Cipolla D; Chesworth T; Agurell E; Ahrens R; Conner D; Dissanayake S; Dolovich M; Doub W; Fuglsang A; García Arieta A; Golden M; Hermann R; Hochhaus G; Holmes S; Lafferty P; Lyapustina S; Nair P; O'Connor D; Parkins D; Peterson I; Reisner C; Sandell D; Singh GJ; Weda M; Watson P
    J Aerosol Med Pulm Drug Deliv; 2012 Jun; 25(3):117-39. PubMed ID: 22413806
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Patient Focus and Regulatory Considerations for Inhalation Device Design: Report from the 2015 IPAC-RS/ISAM Workshop.
    Roche N; Scheuch G; Pritchard JN; Nopitsch-Mai C; Lakhani DA; Saluja B; Jamieson J; Dundon A; Wallace R; Holmes S; Cipolla D; Dolovich MB; Shah SA; Lyapustina S
    J Aerosol Med Pulm Drug Deliv; 2017 Feb; 30(1):1-13. PubMed ID: 27537608
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Demonstrating Bioequivalence of Locally Acting Orally Inhaled Drug Products (OIPs): Workshop Summary Report.
    Adams WP; Ahrens RC; Chen ML; Christopher D; Chowdhury BA; Conner DP; Dalby R; Fitzgerald K; Hendeles L; Hickey AJ; Hochhaus G; Laube BL; Lucas P; Lee SL; Lyapustina S; Li B; O'Connor D; Parikh N; Parkins DA; Peri P; Pitcairn GR; Riebe M; Roy P; Shah T; Singh GJ; Sharp SS; Suman JD; Weda M; Woodcock J; Yu L
    J Aerosol Med Pulm Drug Deliv; 2010 Feb; 23(1):1-29. PubMed ID: 20131983
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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]  

  • 5. Establishing bioequivalence for inhaled drugs; weighing the evidence.
    Daley-Yates PT; Parkins DA
    Expert Opin Drug Deliv; 2011 Oct; 8(10):1297-308. PubMed ID: 21699442
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Performance of the Population Bioequivalence (PBE) Statistical Test Using an IPAC-RS Database of Delivered Dose from Metered Dose Inhalers.
    Morgan B; Chen S; Christopher D; Långström G; Wiggenhorn C; Burmeister Getz E; Beresford H; Hoffelder T; Acerbi D; Andrews S; Berry M; Dey M; Joshi K; McKenry M; Pertile M; Strickland H; Wilcox D; Lyapustina S
    AAPS PharmSciTech; 2018 Apr; 19(3):1410-1425. PubMed ID: 29435904
    [TBL] [Abstract][Full Text] [Related]  

  • 7. 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]  

  • 8. European Regulatory Developments for Orally Inhaled and Nasal Drug Products.
    Santos C; Marco G; Nagao LM; Castro E; Chesworth T
    AAPS PharmSciTech; 2018 Oct; 19(7):3134-3140. PubMed ID: 30128799
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Improved laboratory test methods for orally inhaled products.
    Mitchell JP; Nagel MW
    Ther Deliv; 2013 Aug; 4(8):1003-26. PubMed ID: 23919476
    [TBL] [Abstract][Full Text] [Related]  

  • 10. In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches.
    Forbes B; Bäckman P; Christopher D; Dolovich M; Li BV; Morgan B
    AAPS J; 2015 Jul; 17(4):837-52. PubMed ID: 25940082
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Evaluation of comparative performance of orally inhaled drug products in view of the classical bioequivalence paradigms: an analysis of the current scientific and regulatory dilemmas of inhaler evaluation.
    Horhota ST
    J Aerosol Med Pulm Drug Deliv; 2014 Dec; 27(6):408-13. PubMed ID: 25237840
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Product Quality Research Institute evaluation of cascade impactor profiles of pharmaceutical aerosols. Part 3. Final report on a statistical procedure for determining equivalence.
    Christopher D; Adams W; Amann A; Bertha C; Byron PR; Doub W; Dunbar C; Hauck W; Lyapustina S; Mitchell J; Morgan B; Nichols S; Pan Z; Singh GJ; Tougas T; Tsong Y; Wolff R; Wyka B
    AAPS PharmSciTech; 2007 Nov; 8(4):E90. PubMed ID: 18181550
    [TBL] [Abstract][Full Text] [Related]  

  • 13. 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]  

  • 14. Sample Size Estimation for the U.S. Food and Drug Administration's In Vitro Population Bioequivalence Test of DPIs, MDIs, Nasal Sprays, and Nebules.
    Fuglsang A
    J Aerosol Med Pulm Drug Deliv; 2018 Apr; 31(2):109-110. PubMed ID: 28880704
    [No Abstract]   [Full Text] [Related]  

  • 15. 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]  

  • 16. Artificial neural network prediction of the patterns of deposition of polydisperse aerosols within human lungs.
    Nazir J; Barlow DJ; Jayne Lawrence M; Shrubb I
    J Pharm Sci; 2005 Sep; 94(9):1986-97. PubMed ID: 16052546
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Commentary on the FDA draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action: an industry view.
    Harrison LI
    J Clin Pharmacol; 2000 Jul; 40(7):701-7. PubMed ID: 10883410
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Foreign particles testing in orally inhaled and nasal drug products.
    Blanchard J; Coleman J; Hayling CD; Ghaderi R; Haeberlin B; Hart J; Jensen S; Malcolmson R; Mittelman S; Nagao LM; Sekulic S; Snodgrass-Pilla C; Sundahl M; Thompson G; Wolff R; ;
    Pharm Res; 2004 Dec; 21(12):2137-47. PubMed ID: 15648243
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Laboratory Performance Testing of Aqueous Nasal Inhalation Products for Droplet/Particle Size Distribution: an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS).
    Doub WH; Suman JM; Copley M; Goodey AP; Hosseini S; Mitchell JP
    AAPS PharmSciTech; 2023 Oct; 24(7):208. PubMed ID: 37817001
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Validation of radiolabeling of drug formulations for aerosol deposition assessment of orally inhaled products.
    Devadason SG; Chan HK; Haeussermann S; Kietzig C; Kuehl PJ; Newman S; Sommerer K; Taylor G
    J Aerosol Med Pulm Drug Deliv; 2012 Dec; 25 Suppl 1():S6-9. PubMed ID: 23215848
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.