BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

410 related articles for article (PubMed ID: 28964950)

  • 1. The Global Bioequivalence Harmonization Initiative: Summary report for EUFEPS international conference.
    Chen ML; Blume H; Beuerle G; Davit B; Mehta M; Potthast H; Schug B; Tsang YC; Wedemeyer RS; Weitschies W; Welink J
    Eur J Pharm Sci; 2018 Jan; 111():153-157. PubMed ID: 28964950
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Summary report of second EUFEPS/AAPS conference on global harmonization in bioequivalence.
    Chen ML; Blume H; Beuerle G; Mehta M; Potthast H; Brandt A; Schug BS; Ducharme M; Endrenyi L; Gallicano K; Schuirmann D; Welink J
    Eur J Pharm Sci; 2019 Jan; 127():24-28. PubMed ID: 30342171
    [TBL] [Abstract][Full Text] [Related]  

  • 3. The global bioequivalence harmonisation initiative: Report of EUFEPS/AAPS third conference.
    Mehta M; Blume H; Beuerle G; Tampal N; Schug B; Potthast H; Jiang W; Wilson C
    Eur J Pharm Sci; 2020 Aug; 151():105383. PubMed ID: 32473200
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.
    Chen ML; Shah VP; Crommelin DJ; Shargel L; Bashaw D; Bhatti M; Blume H; Dressman J; Ducharme M; Fackler P; Hyslop T; Lutter L; Morais J; Ormsby E; Thomas S; Tsang YC; Velagapudi R; Yu LX
    Eur J Pharm Sci; 2011 Nov; 44(4):506-13. PubMed ID: 21946259
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.
    Chen ML; Shah VP; Crommelin DJ; Shargel L; Bashaw D; Bhatti M; Blume H; Dressman J; Ducharme M; Fackler P; Hyslop T; Lutter L; Morais J; Ormsby E; Thomas S; Tsang YC; Velagapudi R; Yu LX
    AAPS J; 2011 Dec; 13(4):556-64. PubMed ID: 21845486
    [TBL] [Abstract][Full Text] [Related]  

  • 6. The Global Bioequivalence Harmonisation Initiative (GBHI): Report of EUFEPS/AAPS fourth conference.
    Hh B; M M; G B; A D; G H; W J; A K; J L; H P; B S; A S; N T; Tsang YC; J W; J W
    Eur J Pharm Sci; 2021 Dec; 167():105987. PubMed ID: 34481066
    [TBL] [Abstract][Full Text] [Related]  

  • 7. The Global Bioequivalence Harmonisation Initiative (GBHI): Report of the fifth international EUFEPS/AAPS conference.
    Mehta M; Schug B; Blume HH; Beuerle G; Jiang W; Koenig J; Paixao P; Tampal N; Tsang YC; Walstab J; Wedemeyer R; Welink J
    Eur J Pharm Sci; 2023 Nov; 190():106566. PubMed ID: 37591469
    [TBL] [Abstract][Full Text] [Related]  

  • 8. 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]  

  • 9. The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health.
    Molzon JA; Giaquinto A; Lindstrom L; Tominaga T; Ward M; Doerr P; Hunt L; Rago L
    Clin Pharmacol Ther; 2011 Apr; 89(4):503-12. PubMed ID: 21326288
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Network on veterinary medicines initiated by the European Federation For Pharmaceutical Sciences.
    Mochel JP; Tyden E; Hellmann K; Vendrig JC; Şenel S; Dencker L; Cristina RT; Linden H; Schmerold I
    J Vet Pharmacol Ther; 2018 Jun; 41(3):378-383. PubMed ID: 29266320
    [TBL] [Abstract][Full Text] [Related]  

  • 11. 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]  

  • 12. The Discriminatory Power of the BCS-Based Biowaiver: A Retrospective With Focus on Essential Medicines.
    Hofsäss MA; Dressman JB
    J Pharm Sci; 2019 Sep; 108(9):2824-2837. PubMed ID: 31059698
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.
    Mehta MU; Uppoor RS; Conner DP; Seo P; Vaidyanathan J; Volpe DA; Stier E; Chilukuri D; Dorantes A; Ghosh T; Mandula H; Raines K; Dhanormchitphong P; Woodcock J; Yu LX
    Mol Pharm; 2017 Dec; 14(12):4334-4338. PubMed ID: 29076742
    [TBL] [Abstract][Full Text] [Related]  

  • 14. In vitro and In silico biopharmaceutic regulatory guidelines for generic bioequivalence for oral products: Comparison among various regulatory agencies.
    Kollipara S; Ahmed T; Bhattiprolu AK; Chachad S
    Biopharm Drug Dispos; 2021 Jul; 42(7):297-318. PubMed ID: 34019712
    [TBL] [Abstract][Full Text] [Related]  

  • 15. 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]  

  • 16. Bio-International 92, conference on bioavailability, bioequivalence, and pharmacokinetic studies.
    Blume HH; Midha KK
    J Pharm Sci; 1993 Nov; 82(11):1186-9. PubMed ID: 7904641
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Summary workshop report: bioequivalence, biopharmaceutics classification system, and beyond.
    Polli JE; Abrahamsson BS; Yu LX; Amidon GL; Baldoni JM; Cook JA; Fackler P; Hartauer K; Johnston G; Krill SL; Lipper RA; Malick WA; Shah VP; Sun D; Winkle HN; Wu Y; Zhang H
    AAPS J; 2008 Jun; 10(2):373-9. PubMed ID: 18679807
    [TBL] [Abstract][Full Text] [Related]  

  • 18. 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]  

  • 19. BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements.
    Davit BM; Kanfer I; Tsang YC; Cardot JM
    AAPS J; 2016 May; 18(3):612-8. PubMed ID: 26943914
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Understanding the scientific issues embedded in the generic drug approval process.
    Welage LS; Kirking DM; Ascione FJ; Gaither CA
    J Am Pharm Assoc (Wash); 2001; 41(6):856-67. PubMed ID: 11765111
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 21.