Zobrazeno 1 - 10
of 15
pro vyhledávání: '"Cauchon NS"'
Akademický článek
Tento výsledek nelze pro nepřihlášené uživatele zobrazit.
K zobrazení výsledku je třeba se přihlásit.
K zobrazení výsledku je třeba se přihlásit.
Akademický článek
Tento výsledek nelze pro nepřihlášené uživatele zobrazit.
K zobrazení výsledku je třeba se přihlásit.
K zobrazení výsledku je třeba se přihlásit.
Akademický článek
Tento výsledek nelze pro nepřihlášené uživatele zobrazit.
K zobrazení výsledku je třeba se přihlásit.
K zobrazení výsledku je třeba se přihlásit.
Autor:
Algorri M; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, Thousand Oaks, CA 91320, USA., Cauchon NS; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, Thousand Oaks, CA 91320, USA. Electronic address: ncauchon@amgen.com., Christian T; Process Development, Amgen Inc, Thousand Oaks, CA 91320, USA., O'Connell C; Department of Global Regulatory Affairs and Strategy - Global Regulatory and R&D Policy, Amgen Inc, Thousand Oaks, CA 91320, USA., Vaidya P; Department of Global Regulatory Affairs and Strategy - Global Regulatory and R&D Policy, Amgen Inc, Thousand Oaks, CA 91320, USA.
Publikováno v:
Journal of pharmaceutical sciences [J Pharm Sci] 2023 Apr; Vol. 112 (4), pp. 922-936. Date of Electronic Publication: 2023 Feb 03.
Autor:
Beierle J; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA., Algorri M; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA., Cortés M; Department of Physiology, Johns Hopkins University School of Medicine, Baltimore, MD 21205 USA., Cauchon NS; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA., Lennard A; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA., Kirwan JP; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA., Oghamian S; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA., Abernathy MJ; Department of Global Regulatory Affairs and Strategy - CMC, Amgen Inc, CA 91320 Thousand Oaks, USA.
Publikováno v:
AAPS open [AAPS Open] 2023; Vol. 9 (1), pp. 11. Date of Electronic Publication: 2023 May 08.
Autor:
Ahluwalia K; Department of Global Regulatory Affairs - CMC, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA; University of Southern California, School of Pharmacy, 1985 Zonal Ave, Los Angeles, CA 90089, USA., Abernathy MJ; Department of Global Regulatory Affairs - CMC, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Beierle J; Department of Global Regulatory Affairs - CMC, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA., Cauchon NS; Department of Global Regulatory Affairs - CMC, Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA. Electronic address: ncauchon@amgen.com., Cronin D; Cognition Corporation, 24 Hartwell Ave, Lexington, MA 02421, USA., Gaiki S; Biotherapeutic Development & Supply, Janssen Pharmaceuticals, 1000 Route 202 South, Raritan, NJ 08807, USA., Lennard A; Department of Global Regulatory Affairs - CMC; Amgen Ltd, 1 Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom., Mady P; Product Quality Management, Janssen Pharmaceuticals, 1000 Route 202 South, Raritan, NJ 08807, USA., McGorry M; Biotherapeutic Development & Supply, Janssen Pharmaceuticals, Barnahely, Ringaskiddy, Co.Cork, Ireland., Sugrue-Richards K; Department of Global Regulatory Affairs - CMC, Amgen Inc., 40 Technology Way West Greenwich, RI 02817, USA., Xue G; Biotherapeutic Development & Supply, Janssen Pharmaceuticals, 200 Great Valley Pkwy, Malvern, PA 10355, USA.
Publikováno v:
Journal of pharmaceutical sciences [J Pharm Sci] 2022 May; Vol. 111 (5), pp. 1232-1244. Date of Electronic Publication: 2021 Oct 02.
Autor:
Algorri M; Department of Global Regulatory Affairs and Strategy-CMC, Amgen Inc, Thousand Oaks, California 91320, USA., Abernathy MJ; Department of Global Regulatory Affairs and Strategy-CMC, Amgen Inc, Thousand Oaks, California 91320, USA., Cauchon NS; Department of Global Regulatory Affairs and Strategy-CMC, Amgen Inc, Thousand Oaks, California 91320, USA. Electronic address: ncauchon@amgen.com., Christian TR; Process Development, Amgen Inc, Thousand Oaks, CA 91320, USA., Lamm CF; Global Regulatory Affairs-CMC, Merck & Co., Inc., Kenilworth, New Jersey, 07033, USA., Moore CMV; Global Quality and Compliance, Organon, Jersey City, New Jersey, 07302, USA.
Publikováno v:
Journal of pharmaceutical sciences [J Pharm Sci] 2022 Mar; Vol. 111 (3), pp. 593-607. Date of Electronic Publication: 2021 Aug 31.
Autor:
Algorri M; Amgen Inc., Thousand Oaks, CA USA., Acharya A; Merck & Co., Inc., Kenilworth, NJ USA., Bernstein J; Live Oak Pharmaceutical Consulting, Inc., Raleigh, NC USA., Cauchon NS; Amgen Inc., Thousand Oaks, CA USA., Chen XH; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of New Drug Products, Silver Spring, MD USA., Huynh-Ba K; Pharmalytik, LLC, Newark, DE USA., Krantz C; Seagen, Inc., Bothell, WA USA., Li T; Seagen, Inc., Bothell, WA USA., Li Y; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of Pharmaceutical Manufacturing Assessment, Silver Spring, MD USA., McLamore S; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of New Drug Products, Silver Spring, MD USA., Roberts SW; Novo Nordisk A/S, Vandtårnsvej 114, DK-2860 Søborg, Denmark., Schwinke D; AbbVie, North Chicago, IL USA., Shah R; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of Pharmaceutical Manufacturing Assessment, Silver Spring, MD USA., Schirmer A; Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT USA., Strickland H; GlaxoSmithKline US, Research Triangle Park, NC USA., Tang K; Genentech, Inc., South San Francisco, CA USA., Watson T; Pfizer Inc., Groton, CT USA.
Publikováno v:
AAPS open [AAPS Open] 2022; Vol. 8 (1), pp. 19. Date of Electronic Publication: 2022 Dec 05.
Autor:
Roberts SW; Novo Nordisk A/S, Vandtårnsvej 114, DK-2860, Søborg, Denmark. osrb@novonordisk.com., Lennard A; Amgen Ltd., Uxbridge, UK., Mohan G; Merck & Co., Inc., Kenilworth, New Jersey, USA., Bernstein J; Live Oak Pharmaceutical Consulting, Inc., Raleigh, North Carolina, USA., Cauchon NS; Amgen Inc., Thousand Oaks, California, USA., Cole S; Live Oak Pharmaceutical Consulting, Inc., Raleigh, North Carolina, USA., Curristin N; Live Oak Pharmaceutical Consulting, Inc., Raleigh, North Carolina, USA., Huynh-Ba K; Pharmalytik, LLC, Newark, Delaware, USA., Kolz CN; Pfizer Inc., Groton, Connecticut, USA., Murti C; Merck & Co., Inc., Kenilworth, New Jersey, USA., Tang K; Genentech, Inc., South San Francisco, California, USA.
Publikováno v:
The AAPS journal [AAPS J] 2021 Jul 13; Vol. 23 (4), pp. 94. Date of Electronic Publication: 2021 Jul 13.
Autor:
Gutierrez L; Global Regulatory Affairs-CMC, Amgen Inc, Thousand Oaks, CA 91320, USA; University of Southern California, School of Pharmacy, Los Angeles, CA 90089, USA., Cauchon NS; Global Regulatory Affairs-CMC, Amgen Inc, Thousand Oaks, CA 91320, USA. Electronic address: ncauchon@amgen.com., Christian TR; Process Development, Amgen Inc, Thousand Oaks, CA 91320, USA., Giffin MJ; Process Development, Amgen Inc, Thousand Oaks, CA 91320, USA., Abernathy MJ; Global Regulatory Affairs-CMC, Amgen Inc, Thousand Oaks, CA 91320, USA.
Publikováno v:
Journal of pharmaceutical sciences [J Pharm Sci] 2020 Dec; Vol. 109 (12), pp. 3524-3534. Date of Electronic Publication: 2020 Sep 21.