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 *

137 related articles for article (PubMed ID: 25641690)

  • 1. Product quality for nanomaterials: current U.S. experience and perspective.
    Tyner KM; Zou P; Yang X; Zhang H; Cruz CN; Lee SL
    Wiley Interdiscip Rev Nanomed Nanobiotechnol; 2015; 7(5):640-54. PubMed ID: 25641690
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Considerations when submitting nanotherapeutics to FDA/CDER for regulatory review.
    Tyner K; Sadrieh N
    Methods Mol Biol; 2011; 697():17-31. PubMed ID: 21116951
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Nanotherapeutics--product development along the "nanomaterial" discussion.
    Wacker MG
    J Pharm Sci; 2014 Mar; 103(3):777-84. PubMed ID: 24481705
    [TBL] [Abstract][Full Text] [Related]  

  • 4. The evolving landscape of drug products containing nanomaterials in the United States.
    D'Mello SR; Cruz CN; Chen ML; Kapoor M; Lee SL; Tyner KM
    Nat Nanotechnol; 2017 Jul; 12(6):523-529. PubMed ID: 28436961
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: "Drug Products, Including Biological Products, that Contain Nanomaterials".
    de Vlieger JSB; Crommelin DJA; Tyner K; Drummond DC; Jiang W; McNeil SE; Neervannan S; Crist RM; Shah VP
    AAPS J; 2019 Apr; 21(4):56. PubMed ID: 30997588
    [TBL] [Abstract][Full Text] [Related]  

  • 6. How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.
    Tyner KM; Zheng N; Choi S; Xu X; Zou P; Jiang W; Guo C; Cruz CN
    AAPS J; 2017 Jul; 19(4):1071-1083. PubMed ID: 28421428
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Pharmaceutical impurities: regulatory perspective for Abbreviated New Drug Applications.
    Basak AK; Raw AS; Al Hakim AH; Furness S; Samaan NI; Gill DS; Patel HB; Powers RF; Yu L
    Adv Drug Deliv Rev; 2007 Jan; 59(1):64-72. PubMed ID: 17196703
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Regulatory perspective on the importance of ADME assessment of nanoscale material containing drugs.
    Zolnik BS; Sadrieh N
    Adv Drug Deliv Rev; 2009 Jun; 61(6):422-7. PubMed ID: 19389437
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Current regulatory issues in cell and tissue therapy.
    Burger SR
    Cytotherapy; 2003; 5(4):289-98. PubMed ID: 12944234
    [TBL] [Abstract][Full Text] [Related]  

  • 10. A global view of regulations affecting nanomaterials.
    Hansen SF
    Wiley Interdiscip Rev Nanomed Nanobiotechnol; 2010; 2(5):441-9. PubMed ID: 20533518
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Liposomal Drug Product Development and Quality: Current US Experience and Perspective.
    Kapoor M; Lee SL; Tyner KM
    AAPS J; 2017 May; 19(3):632-641. PubMed ID: 28160164
    [TBL] [Abstract][Full Text] [Related]  

  • 12. FDA use of international standards in the premarket review process.
    Rechen E; Barth DJ; Marlowe D; Kroger L
    Biomed Instrum Technol; 1998; 32(5):518-26. PubMed ID: 9800008
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Regulatory landscape of nanotechnology and nanoplastics from a global perspective.
    Allan J; Belz S; Hoeveler A; Hugas M; Okuda H; Patri A; Rauscher H; Silva P; Slikker W; Sokull-Kluettgen B; Tong W; Anklam E
    Regul Toxicol Pharmacol; 2021 Jun; 122():104885. PubMed ID: 33617940
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Requirements for submission of labeling for human prescription drugs and biologics in electronic format. Final rule.
    Food and Drug Administration, HHS
    Fed Regist; 2003 Dec; 68(238):69009-20. PubMed ID: 14672084
    [TBL] [Abstract][Full Text] [Related]  

  • 15. 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]  

  • 16. Food and Drug Administration requirements for testing and approval of new radiopharmaceuticals.
    Harapanhalli RS
    Semin Nucl Med; 2010 Sep; 40(5):364-84. PubMed ID: 20674596
    [TBL] [Abstract][Full Text] [Related]  

  • 17. The hierarchy of environmental health and safety practices in the U.S. nanotechnology workplace.
    Engeman CD; Baumgartner L; Carr BM; Fish AM; Meyerhofer JD; Satterfield TA; Holden PA; Harthorn BH
    J Occup Environ Hyg; 2013; 10(9):487-95. PubMed ID: 23927041
    [TBL] [Abstract][Full Text] [Related]  

  • 18. An overview of the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations.
    Knoben JE; Scott GR; Tonelli RJ
    Am J Hosp Pharm; 1990 Dec; 47(12):2696-700. PubMed ID: 2278285
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Nanotechnology in cosmetics.
    Katz LM; Dewan K; Bronaugh RL
    Food Chem Toxicol; 2015 Nov; 85():127-37. PubMed ID: 26159063
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Statistical Considerations in Assessing In Vivo Adhesion with Transdermal and Topical Delivery Systems for New Drug Applications.
    Wang C; Strasinger C; Shen M; Tsong Y
    AAPS J; 2020 Oct; 22(6):137. PubMed ID: 33099695
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 7.