BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

256 related articles for article (PubMed ID: 35078378)

  • 1. Biosimilar development and review process in the BRICS-TM countries: Proposal for a standardized model to improve regulatory performance.
    Rahalkar H; Sheppard A; Salek S
    Expert Rev Clin Pharmacol; 2022 Feb; 15(2):215-236. PubMed ID: 35078378
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Comparison of BRICS-TM Countries' Biosimilar Regulatory Frameworks With Australia, Canada and Switzerland: Benchmarking Best Practices.
    Rahalkar H; Sheppard A; Salek S
    Front Pharmacol; 2021; 12():711361. PubMed ID: 34434109
    [No Abstract]   [Full Text] [Related]  

  • 3. Challenges Faced by the Biopharmaceutical Industry in the Development and Marketing Authorization of Biosimilar Medicines in BRICS-TM Countries: An Exploratory Study.
    Rahalkar H; Sheppard A; Lopez-Morales CA; Lobo L; Salek S
    Pharmaceut Med; 2021 Jul; 35(4):235-251. PubMed ID: 34292558
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Current Regulatory Requirements for Biosimilars in Six Member Countries of BRICS-TM: Challenges and Opportunities.
    Rahalkar H; Sheppard A; Santos GML; Dasgupta C; Perez-Tapia SM; Lopez-Morales CA; Salek S
    Front Med (Lausanne); 2021; 8():726660. PubMed ID: 34568384
    [No Abstract]   [Full Text] [Related]  

  • 5. Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines.
    Rahalkar H; Cetintas HC; Salek S
    Front Pharmacol; 2018; 9():1079. PubMed ID: 30364154
    [No Abstract]   [Full Text] [Related]  

  • 6. Considerations related to comparative clinical studies for biosimilars.
    Rathore AS; Stevenson JG; Chhabra H
    Expert Opin Drug Saf; 2021 Mar; 20(3):265-274. PubMed ID: 33455482
    [No Abstract]   [Full Text] [Related]  

  • 7. Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?
    Rivera VM
    Neurol Ther; 2019 Dec; 8(2):177-184. PubMed ID: 31313222
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Regulatory Perspective of International Agencies for Development of Biosimilar Products (Monoclonal Antibodies): An Overview.
    Sharma A; Khante S; Mahadik KR; Gaikwad VL
    Ther Innov Regul Sci; 2020 Sep; 54(5):965-977. PubMed ID: 31933180
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Assessment of Availability, Clinical Testing, and US Food and Drug Administration Review of Biosimilar Biologic Products.
    Moore TJ; Mouslim MC; Blunt JL; Alexander GC; Shermock KM
    JAMA Intern Med; 2021 Jan; 181(1):52-60. PubMed ID: 33031559
    [TBL] [Abstract][Full Text] [Related]  

  • 10. WHO guidelines on biosimilars: Toward improved access to safe and effective products.
    Kang HN; Wadhwa M; Knezevic I; Ondari C; Simao M
    Ann N Y Acad Sci; 2023 Mar; 1521(1):96-103. PubMed ID: 36694455
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Comparability and biosimilarity: considerations for the healthcare provider.
    Lee JF; Litten JB; Grampp G
    Curr Med Res Opin; 2012 Jun; 28(6):1053-8. PubMed ID: 22519391
    [TBL] [Abstract][Full Text] [Related]  

  • 12. QbD-guided pharmaceutical development of Pembrolizumab biosimilar candidate PSG-024 propelled to industry meeting primary requirements of comparability to Keytruda®.
    Jaffar-Aghaei M; Khanipour F; Maghsoudi A; Sarvestani R; Mohammadian M; Maleki M; Havasi F; Rahmani H; Karagah AH; Kazemali MR
    Eur J Pharm Sci; 2022 Jun; 173():106171. PubMed ID: 35378209
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Understanding the biosimilar approval and extrapolation process-A case study of an epoetin biosimilar.
    Agarwal AB; McBride A
    Crit Rev Oncol Hematol; 2016 Aug; 104():98-107. PubMed ID: 27317353
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Developing the Totality of Evidence for Biosimilars: Regulatory Considerations and Building Confidence for the Healthcare Community.
    Markus R; Liu J; Ramchandani M; Landa D; Born T; Kaur P
    BioDrugs; 2017 Jun; 31(3):175-187. PubMed ID: 28439817
    [TBL] [Abstract][Full Text] [Related]  

  • 15. The process defines the product: what really matters in biosimilar design and production?
    Vulto AG; Jaquez OA
    Rheumatology (Oxford); 2017 Aug; 56(suppl_4):iv14-iv29. PubMed ID: 28903544
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Development of biosimilars.
    Al-Sabbagh A; Olech E; McClellan JE; Kirchhoff CF
    Semin Arthritis Rheum; 2016 Apr; 45(5 Suppl):S11-8. PubMed ID: 26947440
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions.
    Bennett CL; Schoen MW; Hoque S; Witherspoon BJ; Aboulafia DM; Hwang CS; Ray P; Yarnold PR; Chen BK; Schooley B; Taylor MA; Wyatt MD; Hrushesky WJ; Yang YT
    Lancet Oncol; 2020 Dec; 21(12):e575-e588. PubMed ID: 33271114
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022.
    Kuribayashi R; Nakano A; Hariu A; Kishioka Y; Honda F
    BioDrugs; 2023 Jul; 37(4):443-451. PubMed ID: 37227657
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Considerations in the early development of biosimilar products.
    Li EC; Abbas R; Jacobs IA; Yin D
    Drug Discov Today; 2015 May; 20 Suppl 2():1-9. PubMed ID: 25572407
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Clinical and Regulatory Considerations for the Use of Bevacizumab Biosimilars in Metastatic Colorectal Cancer.
    Taïeb J; Aranda E; Raouf S; Dunn H; Arnold D
    Clin Colorectal Cancer; 2021 Mar; 20(1):42-51.e3. PubMed ID: 33243618
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 13.