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 *

285 related articles for article (PubMed ID: 19233075)

  • 1. [European legislation on biological similarity recommendations of the European Agency on Medications concerning drug quality].
    Prugnaud JL
    Nephrol Ther; 2009 Feb; 5 Spec No1():3-5. PubMed ID: 19233075
    [No Abstract]   [Full Text] [Related]  

  • 2. [European legislation on the development of biological similarity: recommendations on the European Agency on Medications with regard to efficacy and safety].
    London G
    Nephrol Ther; 2009 Feb; 5 Spec No1():6-9. PubMed ID: 19233076
    [No Abstract]   [Full Text] [Related]  

  • 3. European regulatory guidelines for biosimilars.
    Wiecek A; Mikhail A
    Nephrol Dial Transplant; 2006 Oct; 21 Suppl 5():v17-20. PubMed ID: 16959790
    [TBL] [Abstract][Full Text] [Related]  

  • 4. The European regulatory experience.
    Lewis JA
    Stat Med; 2002 Oct; 21(19):2931-8. PubMed ID: 12325109
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Development of specifications for biotechnology products--perspective from Europe.
    Trouvin JH
    Dev Biol Stand; 1997; 91():25-30. PubMed ID: 9413679
    [No Abstract]   [Full Text] [Related]  

  • 6. Regulatory environment for allergen-specific immunotherapy.
    Kaul S; May S; Lüttkopf D; Vieths S
    Allergy; 2011 Jun; 66(6):753-64. PubMed ID: 21288251
    [TBL] [Abstract][Full Text] [Related]  

  • 7. QUAD routes out inferior drugs.
    Can Hosp; 1973 May; 50(5):58-9. PubMed ID: 4779804
    [No Abstract]   [Full Text] [Related]  

  • 8. Global perspective on specifications for biotechnology products--perspective from Japan.
    Hayakawa T
    Dev Biol Stand; 1997; 91():15-23. PubMed ID: 9413678
    [No Abstract]   [Full Text] [Related]  

  • 9. A proposed European pharmacopeia monograph for continuous cell lines derived drugs.
    Dorpema JW
    Dev Biol Stand; 1989; 70():113-24. PubMed ID: 2759345
    [No Abstract]   [Full Text] [Related]  

  • 10. Bioequivalence and interchangeability of narrow therapeutic range drugs. Canadian Society for Pharmaceutical Sciences discussion.
    Palylyk-Colwell E; Jamali F; Dryden W; Friesen E; Koven S; Mohamed I; Osmond B; Alessi-Severini S; Sheldon L; Sheldon R; Tam Y; Tsuyuki R; Zhanel G
    J Pharm Pharm Sci; 1998; 1(1):2-7. PubMed ID: 10942966
    [No Abstract]   [Full Text] [Related]  

  • 11. [Bioavailability, proof of efficacy and their consequences for drug legislation (author's transl)].
    Schnieders B
    Arzneimittelforschung; 1976; 26(1A):158-63. PubMed ID: 947195
    [TBL] [Abstract][Full Text] [Related]  

  • 12. WHO Expert Committee on Specifications for Pharmaceutical Preparations.
    World Health Organization
    World Health Organ Tech Rep Ser; 2005; 929():1-142, backcover. PubMed ID: 16353684
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Generic vs. brand name drugs--defining and enforcing standards.
    Lasagna LC
    Internist; 1979 May; 20(4):11, 13. PubMed ID: 10316827
    [No Abstract]   [Full Text] [Related]  

  • 14. [Importance of quality in biotechnology: the case of the first biological similarity of erythropoietin].
    Le Cotonnec JY; Lawny F
    Nephrol Ther; 2009 Feb; 5 Spec No1():10-5. PubMed ID: 19233077
    [No Abstract]   [Full Text] [Related]  

  • 15. Biotechnological products in Pan American Health Organization (PAHO): regional efforts towards harmonization of regulation.
    Pombo ML
    Biologicals; 2011 Sep; 39(5):348. PubMed ID: 21873078
    [No Abstract]   [Full Text] [Related]  

  • 16. WHO expert committee on specifications for pharmaceutical preparations. Fortieth report.
    WHO Expert Committee on Specifications for Pharmaceutical Preparations
    World Health Organ Tech Rep Ser; 2006; 937():1-461, back cover. PubMed ID: 16836287
    [TBL] [Abstract][Full Text] [Related]  

  • 17. An audience with James Greenwood.
    Greenwood J
    Nat Rev Drug Discov; 2008 Jun; 7(6):470. PubMed ID: 18511925
    [No Abstract]   [Full Text] [Related]  

  • 18. A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development.
    Robinson S; Delongeas JL; Donald E; Dreher D; Festag M; Kervyn S; Lampo A; Nahas K; Nogues V; Ockert D; Quinn K; Old S; Pickersgill N; Somers K; Stark C; Stei P; Waterson L; Chapman K
    Regul Toxicol Pharmacol; 2008 Apr; 50(3):345-52. PubMed ID: 18295384
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Striving for standards in bioequivalence assessment: a review.
    Schulz HU; Steinijans VW
    Int J Clin Pharmacol Ther Toxicol; 1991 Aug; 29(8):293-8. PubMed ID: 1743802
    [No Abstract]   [Full Text] [Related]  

  • 20. Equivalence studies for complex active ingredients and dosage forms.
    Bhattycharyya L; Dabbah R; Hauck W; Sheinin E; Yeoman L; Williams R
    AAPS J; 2005 Nov; 7(4):E786-812. PubMed ID: 16594632
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 15.