BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

181 related articles for article (PubMed ID: 28835285)

  • 1. Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs.
    Maeda K; Kaneko M; Narukawa M; Arato T
    Orphanet J Rare Dis; 2017 Aug; 12(1):143. PubMed ID: 28835285
    [TBL] [Abstract][Full Text] [Related]  

  • 2. FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis.
    Michaeli T; Jürges H; Michaeli DT
    BMJ; 2023 May; 381():e073242. PubMed ID: 37160306
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer.
    Kesselheim AS; Myers JA; Avorn J
    JAMA; 2011 Jun; 305(22):2320-6. PubMed ID: 21642684
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Raising orphans: how clinical development programs of drugs for rare and common diseases are different.
    Orfali M; Feldman L; Bhattacharjee V; Harkins P; Kadam S; Lo C; Ravi M; Shringarpure DT; Mardekian J; Cassino C; Coté T
    Clin Pharmacol Ther; 2012 Aug; 92(2):262-4. PubMed ID: 22739137
    [TBL] [Abstract][Full Text] [Related]  

  • 5. The actual status of drug prices and adjustment factors for drug price calculation: an analysis of ultra-orphan drug development in Japan.
    Kawakami A; Masamune K
    Orphanet J Rare Dis; 2022 Nov; 17(1):408. PubMed ID: 36348359
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Randomized Controlled Trial Data for New Drug Application for Rare Diseases in Japan.
    Kubota Y; Narukawa M
    Ther Innov Regul Sci; 2022 Jul; 56(4):659-666. PubMed ID: 35478399
    [TBL] [Abstract][Full Text] [Related]  

  • 7. [Current Status and Issues in Drug Development for Rare Cancers].
    Kashitani Y; Takayama H; Hamada N; Go S; Tagami M; Sugihara T
    Gan To Kagaku Ryoho; 2023 Nov; 50(11):1150-1154. PubMed ID: 38056864
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Review and comparison of clinical evidence submitted to support European Medicines Agency market authorization of orphan-designated oncological treatments.
    Winstone J; Chadda S; Ralston S; Sajosi P
    Orphanet J Rare Dis; 2015 Oct; 10():139. PubMed ID: 26511061
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Budget impact analysis of drugs for ultra-orphan non-oncological diseases in Europe.
    Schlander M; Adarkwah CC; Gandjour A
    Expert Rev Pharmacoecon Outcomes Res; 2015 Feb; 15(1):171-9. PubMed ID: 25312018
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.
    Giannuzzi V; Landi A; Bosone E; Giannuzzi F; Nicotri S; Torrent-Farnell J; Bonifazi F; Felisi M; Bonifazi D; Ceci A
    BMJ Open; 2017 Sep; 7(9):e017358. PubMed ID: 28893754
    [TBL] [Abstract][Full Text] [Related]  

  • 11. [Orphan drugs : New opportunities for the treatment of rare diseases].
    Beck M
    Internist (Berl); 2016 Nov; 57(11):1132-1138. PubMed ID: 27527064
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Post-approval Studies for Rare Disease Treatments and Orphan Drugs.
    Maier WC; Christensen RA; Anderson P
    Adv Exp Med Biol; 2017; 1031():197-205. PubMed ID: 29214573
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Ethical imperatives of timely access to orphan drugs: is possible to reconcile economic incentives and patients' health needs?
    Rodriguez-Monguio R; Spargo T; Seoane-Vazquez E
    Orphanet J Rare Dis; 2017 Jan; 12(1):1. PubMed ID: 28057032
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Developing a patient-directed policy framework for managing orphan and ultra-orphan drugs throughout their lifecycle.
    Menon D; Stafinski T; Dunn A; Wong-Rieger D
    Patient; 2015 Feb; 8(1):103-17. PubMed ID: 25559762
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Pharmacology and drug development in rare diseases: the attractiveness and expertise of the French medical pharmacology.
    Micallef J; Boutouyrie P; Blin O
    Fundam Clin Pharmacol; 2017 Dec; 31(6):685-694. PubMed ID: 28779530
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Pivotal studies of orphan drugs approved for neurological diseases.
    Mitsumoto J; Dorsey ER; Beck CA; Kieburtz K; Griggs RC
    Ann Neurol; 2009 Aug; 66(2):184-90. PubMed ID: 19743448
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Drugs for rare diseases: mixed assessment in Europe.
    Prescrire Int; 2007 Feb; 16(87):36-42. PubMed ID: 17323539
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Novel Treatments for Rare Cancers: The U.S. Orphan Drug Act Is Delivering-A Cross-Sectional Analysis.
    Stockklausner C; Lampert A; Hoffmann GF; Ries M
    Oncologist; 2016 Apr; 21(4):487-93. PubMed ID: 27022038
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Orphan drug development: an economically viable strategy for biopharma R&D.
    Meekings KN; Williams CS; Arrowsmith JE
    Drug Discov Today; 2012 Jul; 17(13-14):660-4. PubMed ID: 22366309
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Cancer drugs for solid tumors approved by the EMA since 2014: an overview of pivotal clinical trials.
    Lasala R; Logreco A; Romagnoli A; Santoleri F; Musicco F; Costantini A
    Eur J Clin Pharmacol; 2020 Jun; 76(6):843-850. PubMed ID: 32125472
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 10.