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 *

184 related articles for article (PubMed ID: 38637407)

  • 1. A Comprehensive Analysis of Biopharmaceutical Products Listed in the FDA's Purple Book.
    Chen F; Zhong H; Chan G; Ouyang D
    AAPS PharmSciTech; 2024 Apr; 25(5):88. PubMed ID: 38637407
    [TBL] [Abstract][Full Text] [Related]  

  • 2. A Comprehensive Scientific Survey of Excipients Used in Currently Marketed, Therapeutic Biological Drug Products.
    Rao VA; Kim JJ; Patel DS; Rains K; Estoll CR
    Pharm Res; 2020 Sep; 37(10):200. PubMed ID: 32968854
    [TBL] [Abstract][Full Text] [Related]  

  • 3. The year's new drugs & biologics 2015 - part II:Trends and highlights that marked a complicated year.
    Graul AI; Cruces E; Dulsat C; Tracy M
    Drugs Today (Barc); 2016 Feb; 52(2):131-63. PubMed ID: 27092342
    [TBL] [Abstract][Full Text] [Related]  

  • 4. The year's new drugs & biologics, 2011.
    Graul AI; Cruces E; Dulsat C; Arias E; Stringer M
    Drugs Today (Barc); 2012 Jan; 48(1):33-77. PubMed ID: 22384459
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Will purple become the new orange? The new FDA purple book for biologics: what does the future hold?
    Sabatelli AD; Alpha-Cobb CJ
    Pharm Pat Anal; 2015; 4(2):63-8. PubMed ID: 25853466
    [No Abstract]   [Full Text] [Related]  

  • 6. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.
    Basile EM; Tolomeo D; Gluck E
    Food Drug Law J; 2009; 64(1):149-69. PubMed ID: 19998744
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Development of syringes and vials for delivery of biologics: current challenges and innovative solutions.
    Yoneda S; Torisu T; Uchiyama S
    Expert Opin Drug Deliv; 2021 Apr; 18(4):459-470. PubMed ID: 33217252
    [TBL] [Abstract][Full Text] [Related]  

  • 8. The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications.
    Purpura CA; Garry EM; Honig N; Case A; Rassen JA
    Clin Pharmacol Ther; 2022 Jan; 111(1):135-144. PubMed ID: 34726771
    [TBL] [Abstract][Full Text] [Related]  

  • 9. FDA's Benefit-Risk Framework for Human Drugs and Biologics: Role in Benefit-Risk Assessment and Analysis of Use for Drug Approvals.
    Lackey L; Thompson G; Eggers S
    Ther Innov Regul Sci; 2021 Jan; 55(1):170-179. PubMed ID: 32779045
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Design control considerations for biologic-device combination products.
    Anderson D; Liu R; Anand Subramony J; Cammack J
    Adv Drug Deliv Rev; 2017 Mar; 112():101-105. PubMed ID: 28088344
    [TBL] [Abstract][Full Text] [Related]  

  • 11. A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations.
    Ghosh I; Gutka H; Krause ME; Clemens R; Kashi RS
    MAbs; 2023; 15(1):2205540. PubMed ID: 37243580
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Extending the US Food and Drug Administration's Postmarket Authorities.
    Fernandez Lynch H; Sachs RE; Lee S; Herder M; Ross JS; Ramachandran R
    JAMA Health Forum; 2023 Jun; 4(6):e231313. PubMed ID: 37294583
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Foreword: Follow-on Biologics: Implementation Challenges and Opportunities.
    Paradise J
    Seton Hall Law Rev; 2011; 41(2):501-10. PubMed ID: 21739728
    [TBL] [Abstract][Full Text] [Related]  

  • 14. The US Food and drug administration: drug information resource for formulary recommendations.
    Marchand HC; Ros BJ; Fine AM; Kremzner ME
    J Manag Care Pharm; 2012; 18(9):713-8. PubMed ID: 23206214
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Excipients in parenteral formulations: selection considerations and effective utilization with small molecules and biologics.
    Rayaprolu BM; Strawser JJ; Anyarambhatla G
    Drug Dev Ind Pharm; 2018 Oct; 44(10):1565-1571. PubMed ID: 29863908
    [TBL] [Abstract][Full Text] [Related]  

  • 16. The year's new drugs & biologics, 2013: Part II.
    Graul AI; Navarro D; Dulsat C; Cruces E; Tracy M
    Drugs Today (Barc); 2014 Feb; 50(2):133-58. PubMed ID: 24619590
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Protein drug delivery: current dosage form profile and formulation strategies.
    Geraldes DC; Beraldo-de-Araújo VL; Pardo BOP; Pessoa Junior A; Stephano MA; de Oliveira-Nascimento L
    J Drug Target; 2020 Apr; 28(4):339-355. PubMed ID: 31575296
    [TBL] [Abstract][Full Text] [Related]  

  • 18. New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels.
    Schultz-Knudsen K; Sabaliauskaite U; Hellsten J; Lassen AB; Morant AV
    Ther Innov Regul Sci; 2021 May; 55(3):503-513. PubMed ID: 33230660
    [TBL] [Abstract][Full Text] [Related]  

  • 19. FDA's Unimproved Enforcement of Postmarketing Requirements and Commitments: Implications for Providers and Patients.
    Dauner DG; Dauner KN; Peterson ALH
    Res Social Adm Pharm; 2020 Jun; 16(6):844-847. PubMed ID: 31812502
    [TBL] [Abstract][Full Text] [Related]  

  • 20. When is a medical product too risky? An interview with FDA's top drug official. Interview by Tamar Nordenberg.
    Woodcock J
    FDA Consum; 1999; 33(5):8-11, 13. PubMed ID: 10522164
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 10.