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: 35901943)

  • 1. Regulatory Science Approach in Pharmaceutical Development of Follow-on Versions of Non-Biological Complex Drug Products.
    Zagalo DM; Simões S; Sousa J
    J Pharm Sci; 2022 Oct; 111(10):2687-2713. PubMed ID: 35901943
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.
    Hussaarts L; Mühlebach S; Shah VP; McNeil S; Borchard G; Flühmann B; Weinstein V; Neervannan S; Griffiths E; Jiang W; Wolff-Holz E; Crommelin DJA; de Vlieger JSB
    Ann N Y Acad Sci; 2017 Nov; 1407(1):39-49. PubMed ID: 28445611
    [TBL] [Abstract][Full Text] [Related]  

  • 3. The similarity question for biologicals and non-biological complex drugs.
    Crommelin DJ; Shah VP; Klebovich I; McNeil SE; Weinstein V; Flühmann B; Mühlebach S; de Vlieger JS
    Eur J Pharm Sci; 2015 Aug; 76():10-7. PubMed ID: 25912826
    [TBL] [Abstract][Full Text] [Related]  

  • 4. The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations.
    Klein K; Stolk P; De Bruin ML; Leufkens HGM; Crommelin DJA; De Vlieger JSB
    Eur J Pharm Sci; 2019 May; 133():228-235. PubMed ID: 30953753
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Regulatory challenges of nanomedicines and their follow-on versions: A generic or similar approach?
    Mühlebach S
    Adv Drug Deliv Rev; 2018 Jun; 131():122-131. PubMed ID: 29966685
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Evaluation of Therapeutic Equivalence for the Follow-On Version of Intravenously Administered Non-Biological Complex Drugs.
    Sun Z; Jiang J; Chen X
    Clin Pharmacokinet; 2020 Aug; 59(8):995-1004. PubMed ID: 32328977
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Quality by design (QbD) approach in marketing authorization procedures of Non-Biological Complex Drugs: A critical evaluation.
    Zagalo DM; Sousa J; Simões S
    Eur J Pharm Biopharm; 2022 Sep; 178():1-24. PubMed ID: 35908664
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Complex Generic Products: Insight of Current Regulatory Frameworks in US, EU and Canada and the Need of Harmonisation.
    Lunawat S; Bhat K
    Ther Innov Regul Sci; 2020 Sep; 54(5):991-1000. PubMed ID: 31960290
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Non-biological Complex Drugs (NBCDs): Complex Pharmaceuticals in Need of Individual Robust Clinical Assessment Before Any Therapeutic Equivalence Decision.
    Gaspar RS; Silva-Lima B; Magro F; Alcobia A; da Costa FL; Feio J
    Front Med (Lausanne); 2020; 7():590527. PubMed ID: 33330550
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey.
    Oner ZG; Michel SLJ; Polli JE
    Ann N Y Acad Sci; 2017 Nov; 1407(1):26-38. PubMed ID: 29090833
    [TBL] [Abstract][Full Text] [Related]  

  • 11. 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]  

  • 12. Scientific considerations for complex drugs in light of established and emerging regulatory guidance.
    Holloway C; Mueller-Berghaus J; Lima BS; Lee SL; Wyatt JS; Nicholas JM; Crommelin DJ
    Ann N Y Acad Sci; 2012 Dec; 1276():26-36. PubMed ID: 23193987
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Regulatory considerations for generic products of non-biological complex drugs.
    Liu YH; Chen YS; Tseng T; Jiang ML; Gau CS; Chang LC
    J Food Drug Anal; 2023 Mar; 31(1):20-31. PubMed ID: 37224550
    [TBL] [Abstract][Full Text] [Related]  

  • 14. A pragmatic regulatory approach for complex generics through the U.S. FDA 505(j) or 505(b)(2) approval pathways.
    Klein K; Borchard G; Shah VP; Flühmann B; McNeil SE; de Vlieger JSB
    Ann N Y Acad Sci; 2021 Oct; 1502(1):5-13. PubMed ID: 34296458
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Reflections on FDA Draft Guidance for Products Containing Nanomaterials: Is the Abbreviated New Drug Application (ANDA) a Suitable Pathway for Nanomedicines?
    Emily M; Ioanna N; Scott B; Beat F
    AAPS J; 2018 Aug; 20(5):92. PubMed ID: 30128758
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials.
    Zheng N; Sun DD; Zou P; Jiang W
    AAPS J; 2017 May; 19(3):619-631. PubMed ID: 28116676
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Generic low-molecular-weight heparins: some practical considerations.
    Fareed J; Leong WL; Hoppensteadt DA; Jeske WP; Walenga J; Wahi R; Bick RL
    Semin Thromb Hemost; 2004 Dec; 30(6):703-13. PubMed ID: 15630677
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Tackling the challenges of nanomedicines: are we ready?
    Hertig JB; Shah VP; Flühmann B; Mühlebach S; Stemer G; Surugue J; Moss R; Di Francesco T
    Am J Health Syst Pharm; 2021 Jun; 78(12):1047-1056. PubMed ID: 33599767
    [TBL] [Abstract][Full Text] [Related]  

  • 19. 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]  

  • 20. Statistical and regulatory considerations in assessments of interchangeability of biological drug products.
    Tóthfalusi L; Endrényi L; Chow SC
    Eur J Health Econ; 2014 May; 15 Suppl 1(Suppl 1):S5-11. PubMed ID: 24832831
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 9.