Zobrazeno 1 - 10
of 126
pro vyhledávání: '"Le Merdy M"'
Autor:
Le Merdy M; Simulations Plus, Inc., 42505 10th Street West, Lancaster, CA 93534, USA., Spires J; Simulations Plus, Inc., 42505 10th Street West, Lancaster, CA 93534, USA., Tan ML; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Zhao L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA., Lukacova V; Simulations Plus, Inc., 42505 10th Street West, Lancaster, CA 93534, USA.
Publikováno v:
Pharmaceutics [Pharmaceutics] 2024 Jul 09; Vol. 16 (7). Date of Electronic Publication: 2024 Jul 09.
Autor:
Amaral Silva D; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, CA 93534, USA., Le Merdy M; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, CA 93534, USA., Alam KD; Division of Quantitative Methods and Modeling, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., Wang Y; Division of Quantitative Methods and Modeling, Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, MD 20993, USA., Bao Q; Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA., Malavia N; Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA., Burgess D; Department of Pharmaceutical Sciences, University of Connecticut, Storrs, CT 06269, USA., Lukacova V; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, CA 93534, USA.
Publikováno v:
Pharmaceutics [Pharmaceutics] 2024 Apr 19; Vol. 16 (4). Date of Electronic Publication: 2024 Apr 19.
Autor:
van Osdol WW; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, California, 93534, USA., Novakovic J; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, California, 93534, USA., Le Merdy M; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, California, 93534, USA., Tsakalozou E; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA., Ghosh P; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA., Spires J; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, California, 93534, USA. jessica.spires@simulations-plus.com., Lukacova V; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, California, 93534, USA.
Publikováno v:
AAPS PharmSciTech [AAPS PharmSciTech] 2024 Apr 18; Vol. 25 (5), pp. 87. Date of Electronic Publication: 2024 Apr 18.
Autor:
van Osdol WW; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, California, 93534, USA., Novakovic J; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, California, 93534, USA., Le Merdy M; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, California, 93534, USA., Tsakalozou E; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA., Ghosh P; Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA., Spires J; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, California, 93534, USA. jessica.spires@simulations-plus.com., Lukacova V; Simulations Plus, Incorporated, 42505 10th Street West, Lancaster, California, 93534, USA.
Publikováno v:
AAPS PharmSciTech [AAPS PharmSciTech] 2024 Feb 17; Vol. 25 (3), pp. 39. Date of Electronic Publication: 2024 Feb 17.
Autor:
Le Merdy M; Simulations Plus, Inc., 42505 10th Street West, Lancaster, CA 93534, USA., Szeto KX; Simulations Plus, Inc., 42505 10th Street West, Lancaster, CA 93534, USA., Perrier J; PhinC Development, 36 Rue Victor Basch, 91300 Massy, France., Bolger MB; Simulations Plus, Inc., 42505 10th Street West, Lancaster, CA 93534, USA., Lukacova V; Simulations Plus, Inc., 42505 10th Street West, Lancaster, CA 93534, USA.
Publikováno v:
Pharmaceutics [Pharmaceutics] 2024 Jan 10; Vol. 16 (1). Date of Electronic Publication: 2024 Jan 10.
Autor:
Walenga RL; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Ross.Walenga@fda.hhs.gov., Babiskin AH; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Bhoopathy S; Pharmaron US Lab Services and CGT, Exton, Pennsylvania, USA., Clarke JF; Simcyp Division, Certara UK, Sheffield, UK., De Backer J; FLUIDDA INC., New York, NY, USA., Ducharme M; Learn and Confirm Inc., St-Laurent, Québec, Canada.; University of Montréal, Montréal, Québec, Canada., Kelly M; Global Inhalation R&D, Teva, London, UK., Le Merdy M; Simulations Plus, Inc., Lancaster, California, USA., Yoon M; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA., Roy P; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Publikováno v:
The AAPS journal [AAPS J] 2024 Jan 04; Vol. 26 (1), pp. 12. Date of Electronic Publication: 2024 Jan 04.
Autor:
Tan ML; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Chandran S; Advanced Drug Delivery Research and IVIVC/Biopharmaceutics, Pharmaceutical R & D, Lupin Ltd., Pune, India., Jereb R; Clinical Development, Sandoz Development Centre, Ljubljana, Slovenia., Alam K; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Bies R; Department of Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, State University of New York at BuffaloBuffalo, New York, USA., Kozak D; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Walenga R; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Le Merdy M; Simulations Plus, Inc., Lancaster, California, USA., Babiskin A; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Publikováno v:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2023 May; Vol. 12 (5), pp. 631-638. Date of Electronic Publication: 2023 Mar 20.
Autor:
Le Merdy M; Simulations Plus, Inc., 42505 10th Street West, Lancaster, CA, 93534, USA. maxime.lemerdy@simulations-plus.com., AlQaraghuli F; Simulations Plus, Inc., 42505 10th Street West, Lancaster, CA, 93534, USA., Tan ML; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Walenga R; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Babiskin A; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Zhao L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA., Lukacova V; Simulations Plus, Inc., 42505 10th Street West, Lancaster, CA, 93534, USA.
Publikováno v:
Pharmaceutical research [Pharm Res] 2023 Feb; Vol. 40 (2), pp. 431-447. Date of Electronic Publication: 2022 Sep 23.
Autor:
McAllister M; Pfizer WWRD, Sandwich, Kent CT13 9NJ, UK., Flanagan T; UCB Pharma SA, 1420 Braine l'Alleud, Belgium., Cole S; Medicines & Healthcare Products Regulatory Agency, London E14 4PU, UK., Abend A; Development Sciences and Clinical Supply, Merck & Co., Inc., Rahway, NJ 07033, USA., Kotzagiorgis E; European Medicines Agency, 1083 Amsterdam, The Netherlands., Limberg J; Federal Institute for Drugs and Medical Devices (BfArM), 53175 Bonn, Germany., Mead H; AstraZeneca UK Limited, Macclesfield SK10 2NA, UK., Mangas-Sanjuan V; Department of Pharmacy and Pharmaceutical Technology and Parasitology, University of Valencia, E46100 Burjassot, Spain.; Interuniversity Research Institute for Molecular Recognition and Technological Development, Polytechnic University of Valencia, 46010 Valencia, Spain., Dickinson PA; SEDA Pharmaceutical Development Sciences, Stockport SKB 3GX, UK., Moir A; AstraZeneca UK Limited, Macclesfield SK10 2NA, UK., Pepin X; AstraZeneca UK Limited, Macclesfield SK10 2NA, UK.; Simulations Plus, Inc., Lancaster, CA 93534, USA., Zhou D; AstraZeneca Boston, Boston, MA 02451, USA., Tistaert C; Janssen Research and Development, 2340 Beerse, Belgium., Dokoumetzidis A; Department of Pharmacy, National and Kapodistrian University of Athens, 15784 Athens, Greece., Anand O; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Centre for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, MD 20903, USA., Le Merdy M; Simulations Plus, Inc., Lancaster, CA 93534, USA., Turner DB; Certara UK, Simcyp Division, Sheffield S1 2BJ, UK., Griffin BT; School of Pharmacy, University College Cork, T12 YT20 Cork, Ireland., Darwich A; Division of Health Informatics and Logistics, KTH Royal Institute of Technology, SE-164 40 Stockholm, Sweden., Dressman J; Fraunhofer Institute of Translational Medicine and Pharmacology, 60528 Frankfurt am Main, Germany., Mackie C; Janssen Research and Development, 2340 Beerse, Belgium.
Publikováno v:
Pharmaceutics [Pharmaceutics] 2022 May 07; Vol. 14 (5). Date of Electronic Publication: 2022 May 07.
Autor:
Bartels M; ToxMetrics.com LLC, Midland, Michigan, USA. Electronic address: mjbartels@toxmetrics.com., van Osdol W; Simulations Plus, Lancaster, CA, USA., Le Merdy M; Simulations Plus, Lancaster, CA, USA., Chappelle A; International Isocyanate Institute, Mountain Lakes, NJ, USA., Kuhl A; Huntsman LLC, The Woodlands, Texas, USA., West R; International Isocyanate Institute, Mountain Lakes, NJ, USA.
Publikováno v:
Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2022 Mar; Vol. 129, pp. 105117. Date of Electronic Publication: 2022 Jan 10.