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Wyszukujesz frazę ""biopharmaceutics"" wg kryterium: Temat


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Tytuł :
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Carbamazepine.
Autorzy :
García MA; Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmaceutical and Biomedical Sciences, Johannes Gutenberg University, Mainz, Germany.
Cristofoletti R; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, FL, USA.
Abrahamsson B; Pharmaceutical Development, AstraZeneca R&D, Mölndal, Sweden.
Groot DW; RIVM (National Institute for Public Health and the Environment), Bilthoven, the Netherlands.
Parr A; BioCeutics LLC, Cary, NC, USA.
Polli JE; Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
Mehta M; Division of Clinical Pharmacology, Centre for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.
Shah VP; International Pharmaceutical Federation (FIP), The Hague, the Netherlands.
Tomakazu T; Pharmaceutical Science & Technology Laboratories, Astellas Pharma Inc, Ibaraki, Japan.
Dressman JB; Fraunhofer Institute of Translational Medicine and Pharmacology, ITMP, Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany. Electronic address: .
Langguth P; Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmaceutical and Biomedical Sciences, Johannes Gutenberg University, Mainz, Germany. Electronic address: .
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Źródło :
Journal of pharmaceutical sciences [J Pharm Sci] 2021 May; Vol. 110 (5), pp. 1935-1947. Date of Electronic Publication: 2021 Feb 18.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't; Review
MeSH Terms :
Biopharmaceutics*
Excipients*
Administration, Oral ; Biological Availability ; Carbamazepine ; Dosage Forms ; Solubility ; Therapeutic Equivalency
Czasopismo naukowe
Tytuł :
Development, validation and application of physiologically based biopharmaceutics model to justify the change in dissolution specifications for DRL ABC extended release tablets.
Autorzy :
Jaiswal S; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd, Integrated Product Development Organization (IPDO), Bachupally, India.
Ahmed T; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd, Integrated Product Development Organization (IPDO), Bachupally, India.
Kollipara S; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd, Integrated Product Development Organization (IPDO), Bachupally, India.
Bhargava M; Manufacturing Science And Technology (MSAT) Group, Dr. Reddy's Laboratories Ltd., Formulations Tech Operations (FTO)- Unit III, Bachupally, India.
Chachad S; Biopharmaceutics Group, Global Clinical Management, Dr. Reddy's Laboratories Ltd, Integrated Product Development Organization (IPDO), Bachupally, India.
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Źródło :
Drug development and industrial pharmacy [Drug Dev Ind Pharm] 2021 May; Vol. 47 (5), pp. 778-789. Date of Electronic Publication: 2021 Jun 08.
Typ publikacji :
Journal Article
MeSH Terms :
Biopharmaceutics*
Models, Biological*
Administration, Oral ; Humans ; Solubility ; Tablets ; Therapeutic Equivalency
Czasopismo naukowe
Tytuł :
The Impact of the COVID-19 Pandemic on the Future of Science Careers.
Autorzy :
Perera HM; Department of Chemistry and Biochemistry, Baylor University, Waco, Texas 76798, United States.
Griffin WC; Department of Chemistry and Biochemistry, Baylor University, Waco, Texas 76798, United States.
Kankanamage RNT; Department of Chemistry, University of Connecticut, Storrs, Connecticut 06269, United States.
Pathira Kankanamge LS; Department of Chemistry and Chemical Biology, Northeastern University, 360 Huntington Ave, Boston, Massachusetts 02115, United States.
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Źródło :
Chemical research in toxicology [Chem Res Toxicol] 2021 Mar 15; Vol. 34 (3), pp. 672-674. Date of Electronic Publication: 2020 Dec 23.
Typ publikacji :
Congress
MeSH Terms :
Biopharmaceutics/*economics
COVID-19/*economics
Chemical Industry/*economics
Universities/*economics
Biopharmaceutics/organization & administration ; Biopharmaceutics/trends ; COVID-19/epidemiology ; Chemical Industry/organization & administration ; Humans ; Pandemics ; Research/economics ; Research/organization & administration ; SARS-CoV-2 ; Social Networking ; Unemployment ; Universities/organization & administration ; Workforce
Tytuł :
Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
Autorzy :
Mitra A; Clinical Pharmacology and Pharmacometrics, Janssen Research & Development, Spring House, Pennsylvania. Electronic address: .
Suarez-Sharp S; Regulatory Affairs, Simulations Plus Inc., Lancaster, California.
Pepin XJH; New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.
Flanagan T; Pharmaceutical Development, UCB Pharma SA, Braine l'Alleud, Belgium.
Zhao Y; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.
Kotzagiorgis E; Pharmaceutical Quality Office, European Medicines Agency (EMA), Amsterdam, the Netherlands.
Parrott N; Pharmaceutical Sciences, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Sharan S; 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 (FDA), Silver Spring, Maryland.
Tistaert C; Pharmaceutical Sciences, Janssen Research & Development, Beerse, Belgium.
Heimbach T; PK Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey.
Zolnik B; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.
Sjögren E; Pharmatheus, Uppsala, Sweden.
Wu F; 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 (FDA), Silver Spring, Maryland.
Anand O; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.
Kakar S; PK Sciences, Novartis Institutes for Biomedical Research, East Hanover, New Jersey.
Li M; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.
Veerasingham S; Therapeutic Products Directorate, Health Products and Food Branch, Health Canada, Ottawa, Canada.
Kijima S; Office of Advanced Evaluation with Electronic Data, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.
Lima Santos GM; General Office of Medicines and Biological Products, Brazilian Health Regulatory Agency (Anvisa), Brasilia, Brazil.
Ning B; National Institutes for Food and Drug Control (NIFDC), Beijing, China.
Raines K; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.
Rullo G; Regulatory Excellence, Oncology R&D, AstraZeneca, Gaithersburg, Maryland.
Mandula H; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.
Delvadia P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland.
Dressman J; Fraunhofer Institute for Molecular Biology and Applied Ecology, and Goethe University, Frankfurt, Germany.
Dickinson PA; Seda Pharmaceutical Development Services, Alderley Park, Alderley Edge, Cheshire, UK.
Babiskin A; 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 (FDA), Silver Spring, Maryland.
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Źródło :
Journal of pharmaceutical sciences [J Pharm Sci] 2021 Feb; Vol. 110 (2), pp. 594-609. Date of Electronic Publication: 2020 Nov 03.
Typ publikacji :
Journal Article; Research Support, U.S. Gov't, P.H.S.
MeSH Terms :
Biopharmaceutics*
Pharmaceutical Preparations*
Humans ; Models, Biological ; Research Report ; Solubility
Czasopismo naukowe
Tytuł :
A new application of monosialotetrahexosylganglioside in pharmaceutics: preparation of freeze-thaw-resistant coenzyme Q10 emulsions.
Autorzy :
Wang Y; Department of Pharmacy, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, NO. 44 Xiaoheyan Road, Dadong District, Shenyang 110042, Liaoning Province, PR China.
Wang C; College of Pharmacy, Shenyang Pharmaceutical University, NO. 103 Wenhua Road Shenhe District, Shenyang 110016, Liaoning Province, PR China.
Deng Y; College of Pharmacy, Shenyang Pharmaceutical University, NO. 103 Wenhua Road Shenhe District, Shenyang 110016, Liaoning Province, PR China.
Song Y; College of Pharmacy, Shenyang Pharmaceutical University, NO. 103 Wenhua Road Shenhe District, Shenyang 110016, Liaoning Province, PR China. Electronic address: .
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Źródło :
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2021 Apr 01; Vol. 159, pp. 105701. Date of Electronic Publication: 2021 Jan 09.
Typ publikacji :
Journal Article
MeSH Terms :
Biopharmaceutics*
G(M1) Ganglioside*
Emulsions ; Freezing ; Ubiquinone/analogs & derivatives
Czasopismo naukowe
Tytuł :
Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report.
Autorzy :
Parrott N; Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd. Grenzacherstrasse 124, CH-4070 Basel, Switzerland. Electronic address: .
Suarez-Sharp S; Simulations Plus Inc., 42505 10th Street West, Lancaster, CA 93534, USA.
Kesisoglou F; Pharmaceutical Sciences, Merck & Co., Inc., Kenilworth, NJ, USA.
Pathak SM; Quotient Sciences, Nottingham, United Kingdom.
Good D; Biopharmaceutics, Bristol-Myers Squibb, New Brunswick, NJ, USA.
Wagner C; Pharmaceutical Technologies, Chemical and Pharmaceutical Development, Merck KGaA, Darmstadt, Germany.
Dallmann A; Clinical Pharmacometrics, Research & Development, Pharmaceuticals, Bayer AG, Leverkusen, Germany.
Mullin J; Simulations Plus Inc., 42505 10th Street West, Lancaster, CA 93534, USA.
Patel N; Certara UK Limited, Simcyp Division, Sheffield, UK.
Riedmaier AE; DMPK and Translational Modeling, AbbVie Inc., North Chicago, IL, USA.
Mitra A; Clinical Pharmacology and Pharmacometrics, Janssen Research & Development, Spring House, PA, USA.
Raines K; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, MD, USA.
Butler J; Biopharmaceutics, Drug Product Design & Dev, GlaxoSmithKline R&D, Ware, UK.
Kakhi M; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Li M; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, MD, USA.
Zhao Y; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, MD, USA.
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, MD, USA.
Flanagan T; Pharmaceutical Development, UCB Pharma SA, Braine l'Alleud, Belgium.
Dressman J; Fraunhofer Institute of Translational Medicine and Pharmacology, Carl-von-Noorden-Platz 9, 60596 Frankfurt am Main, Germany.
Pepin X; New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.
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Źródło :
Journal of pharmaceutical sciences [J Pharm Sci] 2021 Feb; Vol. 110 (2), pp. 584-593. Date of Electronic Publication: 2020 Oct 13.
Typ publikacji :
Journal Article; Research Support, U.S. Gov't, P.H.S.
MeSH Terms :
Biopharmaceutics*
Research Report*
Models, Biological ; Solubility ; Therapeutic Equivalency
Czasopismo naukowe
Tytuł :
The Provisional No-Effect Threshold of Sugar Alcohols on Oral Drug Absorption Estimated by Physiologically Based Biopharmaceutics Model.
Autorzy :
Yamane M; Sawai Pharmaceutical Co., Ltd., 5-2-30, Miyahara, Yodogawa-ku, Osaka 532-0003, Japan.
Matsui K; Sawai Pharmaceutical Co., Ltd., 5-2-30, Miyahara, Yodogawa-ku, Osaka 532-0003, Japan. Electronic address: .
Sugihara M; Sawai Pharmaceutical Co., Ltd., 5-2-30, Miyahara, Yodogawa-ku, Osaka 532-0003, Japan.
Tokunaga Y; Sawai Pharmaceutical Co., Ltd., 5-2-30, Miyahara, Yodogawa-ku, Osaka 532-0003, Japan.
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Źródło :
Journal of pharmaceutical sciences [J Pharm Sci] 2021 Jan; Vol. 110 (1), pp. 467-477. Date of Electronic Publication: 2020 May 26.
Typ publikacji :
Journal Article
MeSH Terms :
Biopharmaceutics*
Sugar Alcohols*
Administration, Oral ; Biological Availability ; Excipients ; Intestinal Absorption ; Permeability ; Solubility
Czasopismo naukowe
Tytuł :
A Biopharmetrics Approach for Drug Product Quality Control with Clinical Relevance.
Autorzy :
Duan JZ; 1120 Crestfield Dr, Rockville, MD 20850, USA. Electronic address: .
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Źródło :
Journal of pharmaceutical sciences [J Pharm Sci] 2021 Jan; Vol. 110 (1), pp. 478-488. Date of Electronic Publication: 2020 Aug 15.
Typ publikacji :
Journal Article
MeSH Terms :
Biopharmaceutics*
Pharmaceutical Preparations*
Drug and Narcotic Control ; Quality Control ; Therapeutic Equivalency
Czasopismo naukowe
Tytuł :
Prediction of fasted and fed bioequivalence for immediate release drug products using physiologically based biopharmaceutics modeling (PBBM).
Autorzy :
Jereb R; University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia.
Kristl A; University of Ljubljana, Faculty of Pharmacy, Ljubljana, Slovenia.
Mitra A; Clinical Development, Sandoz Inc (A Novartis Division), Princeton, NJ, USA; Clinical Pharmacology & Pharmacometrics, Janssen R&D, Spring House, PA, USA. Electronic address: .
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Źródło :
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2020 Dec 01; Vol. 155, pp. 105554. Date of Electronic Publication: 2020 Sep 16.
Typ publikacji :
Journal Article
MeSH Terms :
Biopharmaceutics*
Pharmaceutical Preparations*
Humans ; Models, Biological ; Solubility ; Therapeutic Equivalency
Czasopismo naukowe
Tytuł :
BCS-based biowaivers: Extension to paediatrics.
Autorzy :
Martir J; Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom.
Flanagan T; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK; Currently at UCB Pharma, Chemin du Foriest, B - 1420 Braine-l'Alleud, Belgium.
Mann J; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.
Fotaki N; Department of Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom. Electronic address: .
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Źródło :
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2020 Dec 01; Vol. 155, pp. 105549. Date of Electronic Publication: 2020 Sep 14.
Typ publikacji :
Journal Article
MeSH Terms :
Biopharmaceutics*
Pediatrics*
Adult ; Child ; Humans ; Permeability ; Solubility ; Therapeutic Equivalency
Czasopismo naukowe
Tytuł :
IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 4: Prediction accuracy and software comparisons with improved data and modelling strategies.
Autorzy :
Ahmad A; University of Manchester, United Kingdom. Electronic address: .
Pepin X; AstraZeneca, United Kingdom.
Aarons L; University of Manchester, United Kingdom.
Wang Y; University of Manchester, United Kingdom.
Darwich AS; Royal Institute of Technology, Stockholm, Sweden.
Wood JM; AstraZeneca, United Kingdom.
Tannergren C; AstraZeneca, United Kingdom.
Karlsson E; AstraZeneca, United Kingdom.
Patterson C; AstraZeneca, United Kingdom.
Thörn H; AstraZeneca, United Kingdom.
Ruston L; AstraZeneca, United Kingdom.
Mattinson A; AstraZeneca, United Kingdom.
Carlert S; AstraZeneca, United Kingdom.
Berg S; AstraZeneca, United Kingdom.
Murphy D; AstraZeneca, United Kingdom.
Engman H; AstraZeneca, United Kingdom.
Laru J; AstraZeneca, United Kingdom.
Barker R; AstraZeneca, United Kingdom.
Flanagan T; AstraZeneca, United Kingdom.
Abrahamsson B; AstraZeneca, United Kingdom.
Budhdeo S; AstraZeneca, United Kingdom.
Franek F; AstraZeneca, United Kingdom.
Moir A; AstraZeneca, United Kingdom.
Hanisch G; AstraZeneca, United Kingdom.
Pathak SM; Certara, Simcyp Division, United Kingdom.
Turner D; Certara, Simcyp Division, United Kingdom.
Jamei M; Certara, Simcyp Division, United Kingdom.
Brown J; Bristol-Myers Squibb, United Kingdom.
Good D; Bristol-Myers Squibb, United Kingdom.
Vaidhyanathan S; Bristol-Myers Squibb, United Kingdom.
Jackson C; Bristol-Myers Squibb, United Kingdom.
Nicolas O; Sanofi, United States.
Beilles S; Sanofi, United States.
Nguefack JF; Sanofi, United States.
Louit G; Sanofi, United States.
Henrion L; Sanofi, United States.
Ollier C; Sanofi, United States.
Boulu L; Sanofi, United States.
Xu C; Sanofi, United States.
Heimbach T; Novartis, United States.
Ren X; Novartis, United States.
Lin W; Novartis, United States.
Nguyen-Trung AT; Novartis, United States.
Zhang J; Novartis, United States.
He H; Novartis, United States.
Wu F; Novartis, United States.
Bolger MB; Simulation Plus, Inc., United States.
Mullin JM; Simulation Plus, Inc., United States.
van Osdol B; Simulation Plus, Inc., United States.
Szeto K; Simulation Plus, Inc., United States.
Korjamo T; Orion Pharma, Finland.
Pappinen S; Orion Pharma, Finland.
Tuunainen J; Orion Pharma, Finland.
Zhu W; Merck Research Laboratories, Merck & Co., United States.
Xia B; Merck Research Laboratories, Merck & Co., United States.
Daublain P; Merck Research Laboratories, Merck & Co., United States.
Wong S; Pfizer, United States.
Varma MVS; Pfizer, United States.
Modi S; Pfizer, United States.
Schäfer KJ; Boehringer-ingelheim, Germany.
Schmid K; Boehringer-ingelheim, Germany.
Lloyd R; GlaxoSmithKline, United Kingdom.
Patel A; GlaxoSmithKline, United Kingdom.
Tistaert C; Janssen, Belgium.
Bevernage J; Janssen, Belgium.
Nguyen MA; Johannes Gutenberg University of Mainz, Germany.
Lindley D; AbbVie, Germany.
Carr R; AbbVie, Germany.
Rostami-Hodjegan A; University of Manchester, United Kingdom; Certara, Simcyp Division, United Kingdom.
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Źródło :
European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2020 Nov; Vol. 156, pp. 50-63. Date of Electronic Publication: 2020 Aug 14.
Typ publikacji :
Comparative Study; Evaluation Study; Journal Article
MeSH Terms :
Data Analysis*
Models, Biological*
Biopharmaceutics/*standards
Intestinal Absorption/*drug effects
Pharmaceutical Preparations/*metabolism
Software/*standards
Administration, Oral ; Biopharmaceutics/methods ; Clinical Trials as Topic/methods ; Clinical Trials as Topic/standards ; Databases, Factual/standards ; Forecasting ; Humans ; Intestinal Absorption/physiology ; Pharmaceutical Preparations/administration & dosage
Czasopismo naukowe
Tytuł :
[Utility and Potential of Gold (Au) in Pharmaceutical Field].
Autorzy :
Komeda S; Faculty of Pharmaceutical Sciences, Suzuka University of Medical Science.
Higuchi T; Graduate School of Pharmaceutical Sciences, Nagoya City University.
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Źródło :
Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan [Yakugaku Zasshi] 2021; Vol. 141 (3), pp. 303-304.
Typ publikacji :
Editorial
MeSH Terms :
Biopharmaceutics*
Gold*/pharmacology
Gold*/therapeutic use
Antirheumatic Agents ; Auranofin ; Chemistry, Bioinorganic ; Chemistry, Pharmaceutical ; Drug Repositioning ; Humans ; Nanoparticles
Opinia redakcyjna
Tytuł :
Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays.
Autorzy :
Miranda-Pérez de Alejo C; Unit of Modeling and Experimental Biopharmaceutics, Centre of Chemical Bioactive, Central University of Las Villas, Villa Clara, 54830, Santa Clara, Cuba.
Aceituno Álvarez A; ANAMED Department, Institute of Public Health, Chile and Faculty of Pharmacy, University of Valparaiso, Valparaiso, Chile.
Mendes Lima Santos G; General Office of Medicines and Biological Products, Brazilian Health Regulatory Agency (ANVISA), Brasília, DF, Brazil.
Fernández Cervera M; Department of Pharmacy, Institute of Pharmacy and Foods, 17100, Havana, Cuba.
Jung-Cook H; Department of Pharmacy, Chemistry Faculty, UNAM, Mexico, DF, Mexico.
Cabrera-Pérez MÁ; Unit of Modeling and Experimental Biopharmaceutics, Centre of Chemical Bioactive, Central University of Las Villas, Villa Clara, 54830, Santa Clara, Cuba. .
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Źródło :
Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2021 Jan; Vol. 55 (1), pp. 65-81. Date of Electronic Publication: 2020 Jun 29.
Typ publikacji :
Journal Article
MeSH Terms :
Biopharmaceutics*
Pharmaceutical Preparations*
Latin America ; Policy ; Therapeutic Equivalency
Czasopismo naukowe
Tytuł :
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride.
Autorzy :
Charoo NA; Neopharma LLC, Mussafah, Abu Dhabi, United Arab Emirates.
Abdallah DB; Department of Pharmaceutics, Faculty of Pharmacy, Al Ribat University, Khartoum, Sudan.
Parveen T; Neopharma LLC, Mussafah, Abu Dhabi, United Arab Emirates.
Abrahamsson B; Pharmaceutical Development, AstraZeneca R&D, Molndal, Sweden.
Cristofoletti R; Division of Bioequivalence, Brazilian Health Surveillance Agency (Anvisa), Brasilia, Brazil.
Groot DW; RIVM (National Institute for Public Health and the Environment), Bilthoven, the Netherlands.
Langguth P; Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmacy and Biochemistry, Johannes Gutenberg-University, Mainz, Germany.
Parr A; BioCeutics LLC, Cary, North Carolina 28594.
Polli JE; Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland 21201.
Mehta M; Division of Clinical Pharmacology, Centre for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland 20993.
Shah VP; International Pharmaceutical Federation (FIP), The Hague, the Netherlands.
Tajiri T; Astellas Pharma Inc., Analytical Research Laboratories, Yaizu, Japan.
Dressman J; Fraunhofer IME & Institute of Pharmaceutical Technology, Johann Wolfgang Goethe University, Frankfurt am Main, Germany. Electronic address: .
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Źródło :
Journal of pharmaceutical sciences [J Pharm Sci] 2020 Sep; Vol. 109 (9), pp. 2654-2675. Date of Electronic Publication: 2020 Jun 12.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Biopharmaceutics*
Administration, Oral ; Biological Availability ; Dosage Forms ; Moxifloxacin ; Permeability ; Solubility ; Therapeutic Equivalency
Czasopismo naukowe
Tytuł :
Controlling the Reproducibility of AC50 Estimation during Compound Profiling through Bayesian β-Expectation Tolerance Intervals.
Autorzy :
Tendong W; Pharmalex, Mont-Saint-Guibert, Belgium.
Lebrun P; Pharmalex, Mont-Saint-Guibert, Belgium.
Verbist B; Janssen R&D, Translational Medicine and Early Development Statistics, Beerse, Antwerpen, Belgium.
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Źródło :
SLAS discovery : advancing life sciences R & D [SLAS Discov] 2020 Oct; Vol. 25 (9), pp. 1009-1017. Date of Electronic Publication: 2020 May 29.
Typ publikacji :
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms :
Bayes Theorem*
Biopharmaceutics*
Dose-Response Relationship, Drug*
Drug Discovery/*statistics & numerical data
Bias ; Humans ; Reference Standards
Czasopismo naukowe
Tytuł :
A simple and rapid LC-MS/MS and CE-MS/MS analytical strategy for the determination of therapeutic peptides in modern immunotherapeutics and biopharmaceutics.
Autorzy :
Piestansky J; Department of Pharmaceutical Analysis and Nuclear Pharmacy, Faculty of Pharmacy, Comenius University in Bratislava, Odbojarov 10, SK-832 32 Bratislava, Slovak Republic; Toxicological and Antidoping Center, Faculty of Pharmacy, Comenius University in Bratislava, Odbojárov 10, SK-832 32 Bratislava, Slovak Republic. Electronic address: .
Barath P; Institute of Chemistry, Slovak Academy of Sciences, Dubravska cesta 9, SK-845 38 Bratislava, Slovak Republic. Electronic address: .
Majerova P; Institute of Neuroimmunology, Slovak Academy of Sciences, Dubravska cesta 9, SK-845 10 Bratislava, Slovak Republic. Electronic address: .
Galba J; Department of Pharmaceutical Analysis and Nuclear Pharmacy, Faculty of Pharmacy, Comenius University in Bratislava, Odbojarov 10, SK-832 32 Bratislava, Slovak Republic. Electronic address: .
Mikus P; Department of Pharmaceutical Analysis and Nuclear Pharmacy, Faculty of Pharmacy, Comenius University in Bratislava, Odbojarov 10, SK-832 32 Bratislava, Slovak Republic; Toxicological and Antidoping Center, Faculty of Pharmacy, Comenius University in Bratislava, Odbojárov 10, SK-832 32 Bratislava, Slovak Republic. Electronic address: .
Kovacech B; Institute of Neuroimmunology, Slovak Academy of Sciences, Dubravska cesta 9, SK-845 10 Bratislava, Slovak Republic. Electronic address: .
Kovac A; Institute of Neuroimmunology, Slovak Academy of Sciences, Dubravska cesta 9, SK-845 10 Bratislava, Slovak Republic. Electronic address: .
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Źródło :
Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2020 Sep 10; Vol. 189, pp. 113449. Date of Electronic Publication: 2020 Jun 25.
Typ publikacji :
Journal Article
MeSH Terms :
Biopharmaceutics*
Tandem Mass Spectrometry*
Chromatography, High Pressure Liquid ; Chromatography, Liquid ; Immunotherapy ; Limit of Detection ; Peptides ; Reproducibility of Results
Czasopismo naukowe
Tytuł :
Revising Pharmacokinetics of Oral Drug Absorption: I Models Based on Biopharmaceutical/Physiological and Finite Absorption Time Concepts.
Autorzy :
Macheras P; PharmaInformatics Unit, ATHENA Research Center, Athens, Greece. .; Department of Pharmaceutical Sciences, State University of New York (SUNY), Buffalo, New York, USA. .; Department of Pharmacy, National and Kapodistrian University of Athens, University Campus, 15771, Athens, Greece. .
Chryssafidis P; PharmaInformatics Unit, ATHENA Research Center, Athens, Greece.; Department of Pharmacy, National and Kapodistrian University of Athens, University Campus, 15771, Athens, Greece.
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Źródło :
Pharmaceutical research [Pharm Res] 2020 Sep 04; Vol. 37 (10), pp. 187. Date of Electronic Publication: 2020 Sep 04.
Typ publikacji :
Journal Article
MeSH Terms :
Biopharmaceutics*
Intestinal Absorption*
Pharmacokinetics*
Administration, Oral ; Algorithms ; Colon/metabolism ; Computer Simulation ; Gastrointestinal Tract/metabolism ; Gastrointestinal Transit ; Humans ; Intestine, Small/metabolism ; Models, Biological ; Permeability ; Reproducibility of Results ; Solubility
Czasopismo naukowe

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