Zobrazeno 1 - 2
of 2
pro vyhledávání: '"Gorka LS"'
Autor:
Orr RK; Global Regulatory Affairs, Chemistry Manufacturing and Controls, Merck & Co., Inc., 126 E. Lincoln Ave, PO Box 2000, Rahway, New Jersey, 07065, USA. robert.orr@merck.com., Rawalpally T; Regulatory Affairs, Chemistry, Manufacturing and Controls, AstraZeneca BioPharmaceutical Inc., 1 Medimmune Way, Gaithersburg, MD, 20878, USA. thimma.rawalpally@astrazeneca.com., Gorka LS; Global Regulatory Sciences, Chemistry Manufacturing and Controls, Pfizer Inc., Pfizer Research and Development, New York, NY, 10001, USA. lindsey.saunders.gorka@pfizer.com., Bonaga LR; Global Regulatory Affairs, Chemistry Manufacturing and Controls, Merck & Co., Inc., 126 E. Lincoln Ave, PO Box 2000, Rahway, New Jersey, 07065, USA., Schenck L; Oral Formulation Sciences, Merck & Co., Inc., Rahway, NJ, 07065, USA., Osborne S; Global Regulatory Affairs - Chemistry, Manufacturing and Controls, Eli Lilly & Company, Indianapolis, Indiana, 46285, USA., Erdemir D; Drug Product Development, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, New Jersey, 08903, USA., Timpano RJ; Global Regulatory Sciences, Chemistry Manufacturing and Controls, Pfizer Inc., Pfizer Research and Development, Groton, CT, 06340, USA., Zhang H; Chemical Process R&D, Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, 01752, USA.
Publikováno v:
The AAPS journal [AAPS J] 2024 Dec 17; Vol. 27 (1), pp. 16. Date of Electronic Publication: 2024 Dec 17.
Autor:
Schenck L; Process Research & Development, Merck & Co., Inc., Rahway, New Jersey 07065, United States. Electronic address: luke.schenck@merck.com., Patel P; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, MD 20993, United States., Sood R; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, MD 20993, United States., Bonaga L; CMC Pharmaceutical Development and New Products, Merck & Co., Inc., Rahway, New Jersey 07065, United States., Capella P; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, MD 20993, United States., Dirat O; Global Regulatory CMC, Global Product Development, Pfizer R&D UK Ltd, Sandwich, CT13 9NJ, United Kingdom., Erdemir D; Drug Product Development, Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick New Jersey 08903, United States., Ferguson S; SSPC, the SFI Research Centre for Pharmaceuticals, School of Chemical and Bioprocess Engineering, University College Dublin, Belfield, Dublin 4. & National Institute for Bioprocess Research and Training, 24 Foster's Ave, Belfield, Blackrock, Co. Dublin, A94 × 099, Ireland., Gazziola C; Technical Regulatory Affairs, F. Hoffmann-La Roche Ltd, Roche Basel, CH-4051, Basel, Switzerland., Gorka LS; Global Regulatory CMC, Global Product Development, Pfizer Inc., Peapack, NJ 07977, USA., Graham L; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, MD 20993, United States., Ho R; Small Molecule CMC Development, AbbVie Inc., 1 N Waukegan Road, North Chicago, IL 60064, United States., Hoag S; Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland 21201, United States., Hunde E; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, MD 20993, United States., Kline B; Engineering and Materials Sciences, Vertex Pharmaceuticals, 50 Northern Avenue, Boston, MA 02210, United States., Lee SL; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, MD 20993, United States., Madurawe R; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, MD 20993, United States., Marziano I; Chemical Research and Development, Pfizer R&D UK Ltd, Sandwich, CT13 9NJ, United Kingdom., Merritt JM; Synthetic Molecule Design and Development, Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46221, United States., Page S; Global Regulatory CMC, Global Product Development, Pfizer R&D UK Ltd, Sandwich, CT13 9NJ, United Kingdom., Polli J; Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland 21201, United States., Ramanadham M; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, MD 20993, United States., Sapru M; Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, 10903 New Hampshire Ave, Silver Spring, MD 20993, United States., Stevens B; CMC Policy and Advocacy, Global CMC Regulatory Affairs, GSK, 1250 S. Collegeville Rd, Collegeville, PA 19426, United States., Watson T; Global Regulatory CMC, Global Product Development, Pfizer Inc., Groton, CT 06340., Zhang H; Chemical Process R&D, Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough MA, 01752 USA.
Publikováno v:
Journal of pharmaceutical sciences [J Pharm Sci] 2023 Aug; Vol. 112 (8), pp. 2069-2078. Date of Electronic Publication: 2023 Jan 10.