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  1. AU="Ramanadham, Mahesh"
  2. AU="Marco Bolchini"
  3. AU="W. C. Mobley"
  4. AU="Levin, Joshua Z"
  5. AU="V.N. de Jonge"
  6. AU=Zhang Hongliang
  7. AU="Kumagai, A"
  8. AU="Jiménez, Karen Marcela"
  9. AU="Costello, Kelly L"
  10. AU="Sochacki, Mateusz"
  11. AU="Marja Koskuvi"
  12. AU="Hu, Xinfeng"
  13. AU=Sugarman Jeremy AU=Sugarman Jeremy
  14. AU="Tandale, Babasaheb"
  15. AU="Xie, Xinming"

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  1. Artikel ; Online: An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US.

    Fisher, Adam C / Liu, William / Schick, Andreas / Ramanadham, Mahesh / Chatterjee, Sharmista / Brykman, Raphael / Lee, Sau L / Kozlowski, Steven / Boam, Ashley B / Tsinontides, Stelios C / Kopcha, Michael

    International journal of pharmaceutics

    2022  Band 622, Seite(n) 121778

    Abstract: Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product quality, reduced waste, lower costs, and ... ...

    Abstract Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and agility. Some pharmaceutical manufacturers have been hesitant to adopt CM owing to perceived regulatory risks such as increased time to regulatory approval and market entry, more difficulty submitting postapproval changes, and higher inspectional scrutiny. An FDA self-audit of regulatory submissions in the U.S. examined the outcomes, at approval and during the product lifecycle, of continuous manufacturing applications as compared to traditional batch applications. There were no substantial regulatory barriers identified for CM applications related to manufacturing process changes or pre-approval inspections. CM applicants had relatively shorter times to approval and market as compared to similar batch applications, based on the mean or median times to approval (8 or 3 months faster) and marketing (12 or 4 months faster) from submission, translating to an estimated $171-537 M in early revenue benefit.
    Mesh-Begriff(e) Pharmaceutical Preparations ; Technology, Pharmaceutical
    Chemische Substanzen Pharmaceutical Preparations
    Sprache Englisch
    Erscheinungsdatum 2022-04-29
    Erscheinungsland Netherlands
    Dokumenttyp Journal Article
    ZDB-ID 428962-6
    ISSN 1873-3476 ; 0378-5173
    ISSN (online) 1873-3476
    ISSN 0378-5173
    DOI 10.1016/j.ijpharm.2022.121778
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: FDA/M-CERSI Co-Processed API Workshop Proceedings.

    Schenck, Luke / Patel, Paresma / Sood, Ramesh / Bonaga, Llorente / Capella, Peter / Dirat, Olivier / Erdemir, Deniz / Ferguson, Steven / Gazziola, Cinzia / Gorka, Lindsey Saunders / Graham, Laurie / Ho, Raimundo / Hoag, Stephen / Hunde, Ephrem / Kline, Billie / Lee, Sau Larry / Madurawe, Rapti / Marziano, Ivan / Merritt, Jeremy Miles /
    Page, Sharon / Polli, James / Ramanadham, Mahesh / Sapru, Mohan / Stevens, Ben / Watson, Tim / Zhang, Haitao

    Journal of pharmaceutical sciences

    2023  Band 112, Heft 8, Seite(n) 2069–2078

    Abstract: These proceedings contain presentation summaries and discussion highlights from the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) Workshop on Co-processed API, held on July 13 and 14, 2022. This workshop ... ...

    Abstract These proceedings contain presentation summaries and discussion highlights from the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) Workshop on Co-processed API, held on July 13 and 14, 2022. This workshop examined recent advances in the use of co-processed active pharmaceutical ingredients as a technology to improve drug substance physicochemical properties and drug product manufacturing process robustness, and explored proposals for enabling commercialization of these transformative technologies. Regulatory considerations were discussed with a focus on the classification, CMC strategies, and CMC documentation supporting the use of this class of materials from clinical studies through commercialization. The workshop format was split between presentations from industry, academia and the FDA, followed by breakout sessions structured to facilitate discussion. Given co-processed API is a relatively new concept, the authors felt it prudent to compile these proceedings to gain further visibility to topics discussed and perspectives raised during the workshop, particularly during breakout discussions. Disclaimer: This paper reflects discussions that occurred among stakeholder groups, including FDA, on various topics. The topics covered in the paper, including recommendations, therefore, are intended to capture key discussion points. The paper should not be interpreted to reflect alignment on the different topics by the participants, and the recommendations provided should not be used in lieu of FDA published guidance or direct conversations with the Agency about a specific development program. This paper should not be construed to represent FDA's views or policies.
    Sprache Englisch
    Erscheinungsdatum 2023-01-10
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ZDB-ID 3151-3
    ISSN 1520-6017 ; 0022-3549
    ISSN (online) 1520-6017
    ISSN 0022-3549
    DOI 10.1016/j.xphs.2023.01.006
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: Advancing Product Quality: a Summary of the Second FDA/PQRI Conference.

    Yu, Lawrence X / Akseli, Ilgaz / Allen, Barbara / Amidon, Gregory / Bizjak, Tara Gooen / Boam, Ashley / Caulk, Margaret / Doleski, David / Famulare, Joseph / Fisher, Adam C / Furness, Scott / Hasselbalch, Brian / Havel, Henry / Hoag, Stephen W / Iser, Robert / Johnson, Bruce D / Ju, Robert / Katz, Paula / Lacana, Emanuela /
    Lee, Sau L / Lostritto, Richard / McNally, Grace / Mehta, Mehul / Mohan, Ganapathy / Nasr, Moheb / Nosal, Roger / Oates, Mary / O'Connor, Thomas / Polli, Jim / Raju, G K / Ramanadham, Mahesh / Randazzo, Giuseppe / Rosencrance, Susan / Schwendeman, Anna / Selen, Arzu / Seo, Paul / Shah, Vinod / Sood, Ramesh / Thien, Michael P / Tong, Tony / Trout, Bernhardt L / Tyner, Katherine / Vaithiyalingam, Siva / VanTrieste, Martin / Walsh, Fionnuala / Wesdyk, Russell / Woodcock, Janet / Wu, Geoffrey / Wu, Larisa / Yu, Louis / Zezza, Diane

    The AAPS journal

    2016  Band 18, Heft 2, Seite(n) 528–543

    Mesh-Begriff(e) Chemistry, Pharmaceutical/standards ; Chemistry, Pharmaceutical/trends ; Congresses as Topic/standards ; Congresses as Topic/trends ; Drug Industry/standards ; Drug Industry/trends ; Humans ; Quality Control ; United States ; United States Food and Drug Administration/standards ; United States Food and Drug Administration/trends
    Sprache Englisch
    Erscheinungsdatum 2016-02-09
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ISSN 1550-7416
    ISSN (online) 1550-7416
    DOI 10.1208/s12248-016-9874-5
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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