BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

149 related articles for article (PubMed ID: 36530577)

  • 1. Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid.
    Algorri M; Acharya A; Bernstein J; Cauchon NS; Chen XH; Huynh-Ba K; Krantz C; Li T; Li Y; McLamore S; Roberts SW; Schwinke D; Shah R; Schirmer A; Strickland H; Tang K; Watson T
    AAPS Open; 2022; 8(1):19. PubMed ID: 36530577
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Maximizing Regulatory Review Efficiency: The Evolution of the FDA OCE RTOR Pilot.
    Gao YG; Roberts S; Guy A
    Ther Innov Regul Sci; 2022 Mar; 56(2):212-219. PubMed ID: 35006588
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners.
    Hotaki LT; Shrestha A; Bennett MP; Valdes IL; Lee SH; Wang Y; Spillman D; MacAulay T; Hunt M; Gervais J; Mafi M; Panetta V; Looi YH; Shum M; Atiek E; Meincke R; Rohr UP; Ainbinder D; Boehm-Cagan A; Luxenburg O; Cerqueira MR; Mouawad LS; Thees MFRES; Prasad K; de Claro RA
    Ther Innov Regul Sci; 2023 Jul; 57(4):875-885. PubMed ID: 37072651
    [TBL] [Abstract][Full Text] [Related]  

  • 4. Meeting Report: N-Nitrosamine Impurity Control Strategies in the Pharmaceutical and Biotechnology Industries.
    Roberts SW; Lennard A; Mohan G; Bernstein J; Cauchon NS; Cole S; Curristin N; Huynh-Ba K; Kolz CN; Murti C; Tang K
    AAPS J; 2021 Jul; 23(4):94. PubMed ID: 34258657
    [TBL] [Abstract][Full Text] [Related]  

  • 5. U.S. Food and Drug Administration: Initial Experience with the Real-Time Oncology Review Program.
    de Claro RA; Gao JJ; Kim T; Kluetz PG; Theoret MR; Beaver JA; Pazdur R
    Clin Cancer Res; 2021 Jan; 27(1):11-14. PubMed ID: 32816899
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Effect of Project Orbis participation by the Swiss regulator on submission gaps, review times, and drug approval decisions between 2020 and 2022: a comparative analysis.
    Zosso-Pavic M; Li Q; Atiek E; Wolfer A; Rohr UP
    Lancet Oncol; 2024 Jun; 25(6):770-778. PubMed ID: 38754450
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities.
    Feng C; Virparia R; Mui ET
    Ther Innov Regul Sci; 2021 Jul; 55(4):881-888. PubMed ID: 33913098
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Project Orbis: Global Collaborative Review Program.
    de Claro RA; Spillman D; Hotaki LT; Shum M; Mouawad LS; Santos GML; Robinson K; Hunt M; Healy C; Chan A; Looi YH; Rodrigues C; Rohr UP; Walther C; Pazdur R
    Clin Cancer Res; 2020 Dec; 26(24):6412-6416. PubMed ID: 33037016
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Transitioning Chemistry, Manufacturing, and Controls Content With a Structured Data Management Solution: Streamlining Regulatory Submissions.
    Algorri M; Cauchon NS; Abernathy MJ
    J Pharm Sci; 2020 Apr; 109(4):1427-1438. PubMed ID: 32004537
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Conference report: Bioanalysis highlights from the 2012 American Association of Pharmaceutical Scientists National Biotechnology Conference.
    Crisino RM; Geist B; Li J
    Bioanalysis; 2012 Sep; 4(17):2103-7. PubMed ID: 23013391
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Considerations and Regulatory Challenges for Innovative Medicines in Expedited Approval Programs: Breakthrough Therapy and Sakigake Designation.
    Kajiwara E; Shikano M
    Ther Innov Regul Sci; 2020 Jul; 54(4):814-820. PubMed ID: 32557300
    [TBL] [Abstract][Full Text] [Related]  

  • 12. U.S. FDA Drug Approvals for Gynecological Malignancies: A Decade in Review.
    Arora S; Narayan P; Ison G; Berman T; Suzman DL; Wedam S; Prowell TM; Ghosh S; Philip R; Osgood CL; Gao JJ; Shah M; Krol D; Wahby S; Royce M; Brus C; Bloomquist EW; Fiero MH; Tang S; Pazdur R; Ibrahim A; Amiri-Kordestani L; Beaver JA
    Clin Cancer Res; 2022 Mar; 28(6):1058-1071. PubMed ID: 34711631
    [TBL] [Abstract][Full Text] [Related]  

  • 13. PDA Biosimilars Workshop Report (September 27-28, 2018)-Getting It Right the First Time for Biosimilar Marketing Applications.
    Krause S; Lacana E; Welch J; Shapiro M; Downey C; Chung J; Zhou Q; Van Der Plas M; Depatie C; Ingram B; Srebalus-Barnes C; Polozova A; Rellahan B; Choi D; Burdick R; Stangler T; Shacter E
    PDA J Pharm Sci Technol; 2019; 73(4):401-416. PubMed ID: 31004040
    [TBL] [Abstract][Full Text] [Related]  

  • 14. Pediatric formulation development - Challenges of today and strategies for tomorrow: Summary report from M-CERSI workshop 2019.
    Tan DCT; Khong YM; Mount S; Galella E; Mitra B; Charlton S; Kuhli M; Ternik R; Walsh J; Rajapakshe A; Thompson K; Mehrotra S; Santangelo M; Liu J; Dixit T; Schaufelberger D; Jamzad S; Klein S; Hoag SW; Wang J; Fletcher EP; Khurana M; Alexander J; Radden E; Sood R; Selen A
    Eur J Pharm Biopharm; 2021 Jul; 164():54-65. PubMed ID: 33878432
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Advancing Product Quality: a Summary of the Inaugural FDA/PQRI Conference.
    Yu LX; Baker J; Berlam SC; Boam A; Brandreth EJ; Buhse L; Cosgrove T; Doleski D; Ensor L; Famulare J; Ganapathy M; Grampp G; Hussong D; Iser R; Johnston G; Kesisoglou F; Khan M; Kozlowski S; Lacana E; Lee SL; Miller S; Miksinski SP; Moore CM; Mullin T; Raju GK; Raw A; Rosencrance S; Rosolowsky M; Stinavage P; Thomas H; Wesdyk R; Windisch J; Vaithiyalingam S
    AAPS J; 2015 Jul; 17(4):1011-8. PubMed ID: 25840884
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Comparability Considerations and Challenges for Expedited Development Programs for Biological Products.
    Schrieber SJ; Putnam WS; Chow ECY; Cieslak J; Zhuang Y; Martin SW; Hanson P; Maggio F; Rosado LAR
    Drugs R D; 2020 Dec; 20(4):301-306. PubMed ID: 32914381
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Generic Pharmaceutical Association (GPhA) - 2015 CMC Workshop (June 9-10, 2015 - Bethesda, Maryland, USA).
    Komlos D
    Drugs Today (Barc); 2015 Jul; 51(7):429-40. PubMed ID: 26261845
    [TBL] [Abstract][Full Text] [Related]  

  • 18. U.S. FDA Drug Approvals for Breast Cancer: A Decade in Review.
    Arora S; Narayan P; Osgood CL; Wedam S; Prowell TM; Gao JJ; Shah M; Krol D; Wahby S; Royce M; Ghosh S; Philip R; Ison G; Berman T; Brus C; Bloomquist EW; Fiero MH; Tang S; Pazdur R; Ibrahim A; Amiri-Kordestani L; Beaver JA
    Clin Cancer Res; 2022 Mar; 28(6):1072-1086. PubMed ID: 34711632
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Expedited Programs for Serious Conditions: An Update on Breakthrough Therapy Designation.
    Kwok M; Foster T; Steinberg M
    Clin Ther; 2015 Sep; 37(9):2104-20. PubMed ID: 26297571
    [TBL] [Abstract][Full Text] [Related]  

  • 20.
    ; ; . PubMed ID:
    [No Abstract]   [Full Text] [Related]  

    [Next]    [New Search]
    of 8.