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 *

150 related articles for article (PubMed ID: 26272542)

  • 1. Overview: Core technical elements for early product development, evaluation, and control of human cell-based products.
    Hayakawa T
    Biologicals; 2015 Sep; 43(5):410-5. PubMed ID: 26272542
    [TBL] [Abstract][Full Text] [Related]  

  • 2. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 3: Pig islet product manufacturing and release testing.
    Korbutt GS
    Xenotransplantation; 2009; 16(4):223-8. PubMed ID: 19799762
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Evolution of approaches to viral safety issues for biological products.
    Lubiniecki AS
    PDA J Pharm Sci Technol; 2011; 65(6):547-56. PubMed ID: 22294576
    [TBL] [Abstract][Full Text] [Related]  

  • 4. A study on ensuring the quality and safety of pharmaceuticals and medical devices derived from the processing of allogeneic human somatic stem cells.
    Hayakawa T; Aoi T; Umezawa A; Ozawa K; Sato Y; Sawa Y; Matsuyama A; Yamanaka S; Yamato M
    Regen Ther; 2015 Dec; 2():70-80. PubMed ID: 31245461
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Technological progress and challenges towards cGMP manufacturing of human pluripotent stem cells based therapeutic products for allogeneic and autologous cell therapies.
    Abbasalizadeh S; Baharvand H
    Biotechnol Adv; 2013 Dec; 31(8):1600-23. PubMed ID: 23962714
    [TBL] [Abstract][Full Text] [Related]  

  • 6. First update of the International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--Chapter 3: Porcine islet product manufacturing and release testing criteria.
    Rayat GR; Gazda LS; Hawthorne WJ; Hering BJ; Hosking P; Matsumoto S; Rajotte RV
    Xenotransplantation; 2016; 23(1):38-45. PubMed ID: 26923763
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products.
    Hayakawa T; Aoi T; Bravery C; Hoogendoorn K; Knezevic I; Koga J; Maeda D; Matsuyama A; McBlane J; Morio T; Petricciani J; Rao M; Ridgway A; Sato D; Sato Y; Stacey G; Sakamoto N; Trouvin JH; Umezawa A; Yamato M; Yano K; Yokote H; Yoshimatsu K; Zorzi-Morre P
    Biologicals; 2015 Sep; 43(5):283-97. PubMed ID: 26315651
    [TBL] [Abstract][Full Text] [Related]  

  • 8. The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.
    Kroes BH
    J Ethnopharmacol; 2014 Dec; 158 Pt B():449-53. PubMed ID: 25086408
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Scientific considerations for the regulatory evaluation of cell therapy products.
    Petricciani J; Hayakawa T; Stacey G; Trouvin JH; Knezevic I
    Biologicals; 2017 Nov; 50():20-26. PubMed ID: 28888427
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Raising the standard: changes to the Australian Code of Good Manufacturing Practice (cGMP) for human blood and blood components, human tissues and human cellular therapy products.
    Wright C; Velickovic Z; Brown R; Larsen S; Macpherson JL; Gibson J; Rasko JE
    Pathology; 2014 Apr; 46(3):177-83. PubMed ID: 24614714
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore.
    Goh CW; Kellathur SN; Ong LL; Wu X
    Adv Exp Med Biol; 2015; 871():195-212. PubMed ID: 26374220
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.
    Salmikangas P; Schuessler-Lenz M; Ruiz S; Celis P; Reischl I; Menezes-Ferreira M; Flory E; Renner M; Ferry N
    Adv Exp Med Biol; 2015; 871():103-30. PubMed ID: 26374215
    [TBL] [Abstract][Full Text] [Related]  

  • 13. [Science of evaluating the characteristics, quality and safety of biotechnological products: RDNA-derived products, cell culture technology-derived products, gene therapy products, cellular therapy products, and transgenic animal-derived protein products and cellular products].
    Hayakawa T
    Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku; 1999; (117):1-38. PubMed ID: 10859934
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Prospective Evaluation of a Practical Guideline for Managing Positive Sterility Test Results in Cell Therapy Products.
    Panch SR; Bikkani T; Vargas V; Procter J; Atkins JW; Guptill V; Frank KM; Lau AF; Stroncek DF
    Biol Blood Marrow Transplant; 2019 Jan; 25(1):172-178. PubMed ID: 30098394
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Voluntary guidance for the development of tissue-engineered products.
    Omstead DR; Baird LG; Christenson L; Du Moulin G; Tubo R; Maxted DD; Davis J; Gentile FT
    Tissue Eng; 1998; 4(3):239-66. PubMed ID: 9836789
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective.
    McBlane JW; Phul P; Sharpe M
    Pharm Res; 2018 Jun; 35(8):165. PubMed ID: 29943208
    [TBL] [Abstract][Full Text] [Related]  

  • 17. [Strategic considerations on the design and choice of animal models for non-clinical investigations of cell-based medicinal products].
    Lehmann J; Schulz RM; Sanzenbacher R
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2015 Nov; 58(11-12):1215-24. PubMed ID: 26431722
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Microbiological Test Data-Assuring Data Integrity.
    Tidswell EC; Sandle T
    PDA J Pharm Sci Technol; 2018; 72(1):2-14. PubMed ID: 29030529
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Safety and nutritional assessment of GM plants and derived food and feed: the role of animal feeding trials.
    EFSA GMO Panel Working Group on Animal Feeding Trials
    Food Chem Toxicol; 2008 Mar; 46 Suppl 1():S2-70. PubMed ID: 18328408
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Tumorigenicity assessment of human cell-processed therapeutic products.
    Yasuda S; Sato Y
    Biologicals; 2015 Sep; 43(5):416-21. PubMed ID: 26071041
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.