BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

119 related articles for article (PubMed ID: 25959119)

  • 1. Formulations in paediatric investigation plans (PIPs): Introduction to PIP quality section and regulatory framework.
    Wang S
    Int J Pharm; 2015 Aug; 492(1-2):332-4. PubMed ID: 25959119
    [No Abstract]   [Full Text] [Related]  

  • 2. Pediatric formulation issues identified in Paediatric Investigation Plans.
    Quijano Ruiz B; Desfontaine E; Arenas-López S; Wang S
    Expert Rev Clin Pharmacol; 2014 Jan; 7(1):25-30. PubMed ID: 24308789
    [TBL] [Abstract][Full Text] [Related]  

  • 3. More than 5 years of European Paediatric Regulation: statistics and industrial experience.
    Winzenburg G
    Int J Pharm; 2014 Aug; 469(2):260-2. PubMed ID: 24704106
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Quality considerations of paediatric investigation plans for monoclonal antibodies: A regulatory perspective from the MHRA.
    Hussain N; Siapkara A; Branch S
    Int J Pharm; 2015 Aug; 492(1-2):338-40. PubMed ID: 25959114
    [TBL] [Abstract][Full Text] [Related]  

  • 5. European perspectives on pediatric formulations.
    Breitkreutz J
    Clin Ther; 2008 Nov; 30(11):2146-54. PubMed ID: 19108802
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Milk as a medium for pediatric formulations: Experimental findings and regulatory aspects.
    Soulele K; Macheras P
    Int J Pharm; 2015 Aug; 492(1-2):344-5. PubMed ID: 25959116
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Paediatric investigation plans for pain: painfully slow!
    Davies EH; Ollivier CM; Saint Raymond A
    Eur J Clin Pharmacol; 2010 Nov; 66(11):1091-7. PubMed ID: 20821198
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Proposals for model-based paediatric medicinal development within the current European Union regulatory framework.
    Manolis E; Pons G
    Br J Clin Pharmacol; 2009 Oct; 68(4):493-501. PubMed ID: 19843052
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Drug development: EU paediatric legislation, the European Medicines Agency and its Paediatric Committee--adolescents' melanoma as a paradigm.
    Rose K; Senn S
    Pharm Stat; 2014; 13(4):211-3. PubMed ID: 24903307
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Do Paediatric Investigation Plans (PIPs) Advance Paediatric Healthcare?
    Rose K; Walson PD
    Paediatr Drugs; 2017 Dec; 19(6):515-522. PubMed ID: 28889403
    [TBL] [Abstract][Full Text] [Related]  

  • 11. The EU paediatric regulation: still a large discrepancy between therapeutic needs and approved paediatric investigation plans.
    Wimmer S; Rascher W; McCarthy S; Neubert A
    Paediatr Drugs; 2014 Oct; 16(5):397-406. PubMed ID: 25056717
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Progress review of the European Paediatric Regulatory Framework after six years of implementation.
    Mentzer D
    Int J Pharm; 2014 Aug; 469(2):240-3. PubMed ID: 24613178
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Impact of the European paediatric legislation in paediatric rheumatology: past, present and future.
    Ruperto N; Vesely R; Saint-Raymond A; Martini A;
    Ann Rheum Dis; 2013 Dec; 72(12):1893-6. PubMed ID: 23962457
    [TBL] [Abstract][Full Text] [Related]  

  • 14. European Union pediatric legislation jeopardizes worldwide, timely future advances in the care of children with cancer.
    Rose K
    Clin Ther; 2014 Feb; 36(2):163-77. PubMed ID: 24529288
    [TBL] [Abstract][Full Text] [Related]  

  • 15. [Better medicines for children].
    Brasseur D
    Rev Med Brux; 2006; 27 Spec No():Sp25-8. PubMed ID: 21818889
    [TBL] [Abstract][Full Text] [Related]  

  • 16. The pediatric studies initiative: after 15 years have we reached the limits of the law?
    Milne CP; Davis J
    Clin Ther; 2014 Feb; 36(2):156-62. PubMed ID: 24529287
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Juvenile animal studies and pediatric drug development: a European regulatory perspective.
    Carleer J; Karres J
    Birth Defects Res B Dev Reprod Toxicol; 2011 Aug; 92(4):254-60. PubMed ID: 21638754
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Adaptive paediatric investigation plans, a small step to improve regulatory decision making in drug development for children?
    Bauer P; König F
    Pharm Stat; 2016 Sep; 15(5):384-6. PubMed ID: 27400890
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Lack of compliance of European Public Assessment Reports to guidelines for paediatric drug development before the introduction of paediatric investigation plans.
    Piana C; Kliphuis E; Della Pasqua O
    Clin Trials; 2013 Apr; 10(2):269-79. PubMed ID: 23335676
    [TBL] [Abstract][Full Text] [Related]  

  • 20. The use of ethanol in paediatric formulations in New Zealand.
    Svirskis D; Toh M; Ram S
    Eur J Pediatr; 2013 Jul; 172(7):919-26. PubMed ID: 23440480
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 6.