Zobrazeno 1 - 10
of 21 446
pro vyhledávání: '"biopharmaceutics"'
Autor:
Chiang Yu Y; Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD, 21201, USA., Lu D; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Rege B; Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA., Polli JE; Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD, 21201, USA. Electronic address: jpolli@rx.umaryland.edu.
Publikováno v:
Journal of pharmaceutical sciences [J Pharm Sci] 2024 Aug; Vol. 113 (8), pp. 2215-2222. Date of Electronic Publication: 2024 Mar 12.
Autor:
Bhattiprolu AK; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), BachupallyMedchal Malkajgiri District, Hyderabad, Telangana, 500 090, India., Kollipara S; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), BachupallyMedchal Malkajgiri District, Hyderabad, Telangana, 500 090, India., Boddu R; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), BachupallyMedchal Malkajgiri District, Hyderabad, Telangana, 500 090, India., Arumugam A; Clinical Pharmacokinetics, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), BachupallyMedchal Malkajgiri District, Hyderabad, Telangana, 500 090, India., Khan SM; Clinical Pharmacokinetics, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), BachupallyMedchal Malkajgiri District, Hyderabad, Telangana, 500 090, India., Ahmed T; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), BachupallyMedchal Malkajgiri District, Hyderabad, Telangana, 500 090, India. tausifahmed@drreddys.com.; Clinical Pharmacokinetics, Global Clinical Management, Dr. Reddy's Laboratories Ltd., Integrated Product Development Organization (IPDO), BachupallyMedchal Malkajgiri District, Hyderabad, Telangana, 500 090, India. tausifahmed@drreddys.com.
Publikováno v:
AAPS PharmSciTech [AAPS PharmSciTech] 2024 Aug 21; Vol. 25 (7), pp. 193. Date of Electronic Publication: 2024 Aug 21.
Autor:
Pepin X; Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States., Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium., Borges L; ANVISA, SIA Trecho 5́, Guara, Brasília, Federal District 71205-050, Brazil., Cano-Vega M; Drug Product Technologies, Amgen Inc., Thousand Oaks, California 91320-1799, United States., Carducci T; Analytical Commercialization Technology, Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, New Jersey 07065, United States., Chatterjee P; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Chen G; Takeda Development Center Americas Inc., 300 Shire Way, Lexington, Massachusetts 02421, United States., Cristofoletti R; College of Pharmacy, University of Florida, 6550 Sanger Rd., Orlando, Florida 32827, United States., Dallmann A; Bayer HealthCare SAS, 59000 Lille, France, on behalf of Bayer AG, Pharmacometrics/Modeling and Simulation, Systems Pharmacology & Medicine, PBPK, Leverkusen, Germany., Delvadia P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Dressman J; Fraunhofer Institute of Translational Medicine and Pharmacology, Frankfurt am Main 60596, Germany., Fotaki N; University of Bath, Claverton Down, Bath BA2 7AY, United Kingdom., Gray E; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States., Holte Ø; Norwegian Medical Products Agency, Oslo 0213, Norway., Kijima S; Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan., Kotzagiorgis E; European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands., Lennernäs H; Translational Drug Discovery and Development, Department of Pharmaceutical Bioscience, Uppsala University, Uppsala 751 05, Sweden., Lindahl A; Swedish Medical Products Agency, Uppsala 752 37, Sweden., Loebenberg R; Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmontonton T6G 2E1, Canada., Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium., Malamatari M; Medicines & Healthcare Products Regulatory Agency, 10 S Colonnade, London SW1W 9SZ, United Kingdom., McAllister M; Global Biopharmaceutics, Drug Product Design, Pfizer, Sandwich CT13 9NJ, United Kingdom., Mitra A; Clinical Pharmacology, Kura Oncology Inc., Boston, Massachusetts 02210, United States., Moody R; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Mudie D; Global Research and Development, Small Molecules, Lonza, 63045 NE Corporate Pl., Bend, Oregon 97701, United States., Musuamba Tshinanu F; Belgian Federal Agency for Medicines and Health Products, Galileelaan 5/03, Brussel 1210, Belgium., Polli JE; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States., Rege B; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Ren X; PK Sciences/Translational Medicine, BioMedical Research, Novartis, One Health Plaza, East Hanover, New Jersey 07936, United States., Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States., Scherholz M; Pharmaceutical Development, Bristol Myers Squibb, Route 206 & Province Line Road, Princeton, New Jersey 08543, United States., Song I; Takeda Development Center Americas Inc., 300 Shire Way, Lexington, Massachusetts 02421, United States., Stillhart C; Pharmaceutical R&D, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland., Suarez-Sharp S; Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States., Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 431 50, Sweden., Tsakalozou E; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States., Veerasingham S; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott St., Ottawa K1A 0K9, Canada., Wagner C; Global Drug Product Development, Global CMC Development, the Healthcare Business of Merck KGaA, Darmstadt D-64293, Germany., Seo P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.
Publikováno v:
Molecular pharmaceutics [Mol Pharm] 2024 Aug 05; Vol. 21 (8), pp. 3697-3731. Date of Electronic Publication: 2024 Jun 30.
Autor:
Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium., Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, Beerse 2340, Belgium., Seo P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, Maryland 20993, United States., Moody R; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States., Rege B; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20993, United States., Pepin X; Regulatory Affairs, Simulations Plus, Inc., Lancaster, California 93534-7059, United States., Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., 123 East Scott Ave., Rahway, New Jersey 07065, United States., Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 431 83, Sweden., Mitra A; Clinical Pharmacology, Kura Oncology, Inc., Boston, Massachusetts 02210, United States., Suarez-Sharp S; Regulatory Affairs, Simulations Plus, Inc., Lancaster, California 93534-7059, United States., Borges LN; ANVISA, SIA Trecho 5 - Guará, Brasília, Distrito Federal 71205-050, Brazil., Kijima S; Office of New Drug V, Pharmaceutical and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan., Kotzagiorgis E; European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands., Malamatari M; Medicines & Healthcare products Regulatory Agency, 10 South Colonnade, London E14 4PU, United Kingdom., Veerasingham S; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott Street, Ottawa, Ontario K1A 0K9, Canada., Polli JE; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States., Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States.
Publikováno v:
Molecular pharmaceutics [Mol Pharm] 2024 May 06; Vol. 21 (5), pp. 2065-2080. Date of Electronic Publication: 2024 Apr 10.
Autor:
Floroiu A; Department of Pharmacy, Saarland University, 66123 Saarbrücken, Germany; Eurofins PHAST Development GmbH & Co. KG, 78467 Konstanz, Germany. Electronic address: Andreea.Floroiu@bpt.eurofinseu.com., Loretz B; Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Helmholtz Centre for Infection Research, Saarland University, Campus E8 1, 66123 Saarbrücken, Germany., Krämer J; DISSO GmbH, 66424 Homburg, Germany., Lehr CM; Department of Pharmacy, Saarland University, 66123 Saarbrücken, Germany; Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Helmholtz Centre for Infection Research, Saarland University, Campus E8 1, 66123 Saarbrücken, Germany. Electronic address: Claus-Michael.Lehr@helmholtz-hips.de.
Publikováno v:
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2024 Apr; Vol. 197, pp. 114206. Date of Electronic Publication: 2024 Feb 03.
Autor:
Kowthavarapu VK; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA., Charbe NB; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA., Gupta C; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA., Iakovleva T; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA., Stillhart C; Pharmaceutical Research & Development, Formulation & Process Development, F. Hoffmann-La Roche Ltd., 4070, Basel, Switzerland., Parrott NJ; Pharmaceutical Research & Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., 4070, Basel, Switzerland., Schmidt S; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA., Cristofoletti R; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA. rcristofoletti@ufl.edu.
Publikováno v:
The AAPS journal [AAPS J] 2024 Apr 04; Vol. 26 (3), pp. 44. Date of Electronic Publication: 2024 Apr 04.
Autor:
Alaoui Mansouri M; Nano and Molecular Systems Research Unit, University of Oulu, FI-90014 Oulu, Finland; University of Liege (ULiege), CIRM, Vibra-Santé HUB, Laboratory of Pharmaceutical Analytical Chemistry, CHU, B36, B-4000, Liege, Belgium. Electronic address: mohammed.alaouimansouri@oulu.fi., Kharbach M; Research Unit of Mathematical Sciences, University of Oulu, FI-90014 Oulu, Finland. Electronic address: mourad1kharbach@gmail.com., Bouklouze A; Bio-Pharmaceutical and Toxicological Analysis Research Team, Laboratory of Pharmacology and Toxicology, Faculty of Medicine and Pharmacy, University Mohammed V, Rabat, Morocco.
Publikováno v:
Journal of pharmaceutical sciences [J Pharm Sci] 2024 Apr; Vol. 113 (4), pp. 856-865. Date of Electronic Publication: 2023 Dec 08.
Autor:
Fenton OS; Division of Pharmacoengineering and Molecular Pharmaceutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States.
Publikováno v:
Molecular pharmaceutics [Mol Pharm] 2024 Apr 01; Vol. 21 (4), pp. 1551-1552. Date of Electronic Publication: 2024 Mar 25.
Autor:
Hastedt JE; JDP Pharma Consulting, San Carlos, California 94070, United States., Bäckman P; Emmace Consulting, 223 63 Lund, Sweden., Cabal A; Eisai, Woodcliff Lake, New Jersey 07677, United States., Clark A; Aerogen Pharma, San Mateo, California 94402, United States., Ehrhardt C; School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin D02 PN40, Ireland., Forbes B; King's College London, London SE1 9NH, U.K., Hickey AJ; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States.; RTI International, Research Triangle Park, North Carolina 27709, United States., Hochhaus G; University of Florida, Gainesville, Florida 32611, United States., Jiang W; Center for Drug Evaluation and Research, Office of Generic Drugs, Office of Research and Standards, U.S. FDA, Silver Spring, Maryland 20993, United States., Kassinos S; University of Cyprus, 1678 Nicosia, Cyprus., Kuehl PJ; Lovelace Biomedical, Albuquerque, New Mexico 87108, United States., Prime D; Pulmonary Drug Delivery Consultant, Ware Royston, SG8 7ED, U.K., Son YJ; Genentech, South San Francisco, California 94080, United States., Teague S; GlaxoSmithKline, Stevenage SG1 2NY, U.K., Tehler U; Advanced Drug Delivery, Pharmaceutical Sciences, R&D, AstraZeneca, 431 83 Gothenburg, Sweden., Wylie J; Merck & Co., Inc., Rahway, New Jersey 07065, United States.
Publikováno v:
Molecular pharmaceutics [Mol Pharm] 2024 Jan 01; Vol. 21 (1), pp. 164-172. Date of Electronic Publication: 2023 Dec 07.
Autor:
Holzem FL; Department of Physics, Chemistry and Pharmacy, University of Southern Denmark, Campusvej 55, 5230 Odense, Denmark; Pharmaceutical R&D, F. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland., Petrig Schaffland J; Roche Pharmaceutical Research & Early Development, Pre-Clinical CMC, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland., Brandl M; Department of Physics, Chemistry and Pharmacy, University of Southern Denmark, Campusvej 55, 5230 Odense, Denmark., Bauer-Brandl A; Department of Physics, Chemistry and Pharmacy, University of Southern Denmark, Campusvej 55, 5230 Odense, Denmark., Stillhart C; Pharmaceutical R&D, F. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland.
Publikováno v:
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2024 Mar 01; Vol. 194, pp. 106703. Date of Electronic Publication: 2024 Jan 14.