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المؤلفون: Mohammed YH; Therapeutics Research Centre, Frazer Institute, The University of Queensland, Brisbane, Australia. Y.Mohammed@uq.edu.au.; School of Pharmacy, The University of Queensland, Woolloongabba, QLD, 4102, Australia. Y.Mohammed@uq.edu.au., Namjoshi SN; Therapeutics Research Centre, Frazer Institute, The University of Queensland, Brisbane, Australia., Jung N; Institute of Pharmaceutical Technology, Goethe University, Frankfurt, Germany., Windbergs M; Institute of Pharmaceutical Technology, Goethe University, Frankfurt, Germany., Benson HAE; Curtin Medical School, Curtin University, Perth, WA, Australia., Grice JE; Therapeutics Research Centre, Frazer Institute, The University of Queensland, Brisbane, Australia., Raney SG; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA., Roberts MS; Therapeutics Research Centre, Frazer Institute, The University of Queensland, Brisbane, Australia.; School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia.; Therapeutics Research Centre, Basil Hetzel Institute for Translational Medical Research, The Queen Elizabeth Hospital, Adelaide, Australia.

المصدر: Pharmaceutical research [Pharm Res] 2024 Jul; Vol. 41 (7), pp. 1507-1520. Date of Electronic Publication: 2024 Jul 02.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-904X (Electronic) Linking ISSN: 07248741 NLM ISO Abbreviation: Pharm Res Subsets: MEDLINE

مواضيع طبية MeSH: Acyclovir*/pharmacokinetics , Acyclovir*/administration & dosage , Skin Cream*/pharmacokinetics , Skin Cream*/chemistry , Skin Absorption* , Biological Availability* , Antiviral Agents*/pharmacokinetics , Antiviral Agents*/administration & dosage , Antiviral Agents*/chemistry , Therapeutic Equivalency*, Humans ; Administration, Cutaneous ; Skin/metabolism

المؤلفون: Tiffner KI; Institute for Biomedical Research and Technologies (HEALTH), Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria., Ramezanli T; 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., Boulgaropoulos B; Institute for Biomedical Research and Technologies (HEALTH), Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria., Birngruber T; Institute for Biomedical Research and Technologies (HEALTH), Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria., Bodenlenz M; Institute for Biomedical Research and Technologies (HEALTH), Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria., Lackner BC; Institute for Biomedical Research and Technologies (HEALTH), Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria., Raml R; Institute for Biomedical Research and Technologies (HEALTH), Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria., Jiang Y; 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., Raney SG; 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., Sinner F; Institute for Biomedical Research and Technologies (HEALTH), Joanneum Research Forschungsgesellschaft m.b.H, Neue Stiftingtalstrasse 2, 8010, Graz, Austria; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Auenbruggerplatz 15, 8036, Graz, Austria.

المصدر: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2024 Jun 08; Vol. 200, pp. 106827. Date of Electronic Publication: 2024 Jun 08.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Elsevier Science B.V Country of Publication: Netherlands NLM ID: 9317982 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-0720 (Electronic) Linking ISSN: 09280987 NLM ISO Abbreviation: Eur J Pharm Sci Subsets: MEDLINE

المؤلفون: Tsakalozou E; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. Eleftheria.Tsakalozou@fda.hhs.gov., Gong Y; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 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, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Hu M; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Mousa Y; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 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, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Wu F; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Yoon M; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA., Raney SG; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Polli JE; Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland, USA., Schwendeman A; Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, Michigan, USA., Krishnan V; Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, Michigan, USA., Fang L; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 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, US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.

المصدر: The AAPS journal [AAPS J] 2024 Apr 24; Vol. 26 (3), pp. 55. Date of Electronic Publication: 2024 Apr 24.

نوع المنشور: Editorial; Research Support, U.S. Gov't, P.H.S.

بيانات الدورية: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE

مواضيع طبية MeSH: Drugs, Generic*, United States ; Humans ; Drug Development/methods ; United States Food and Drug Administration ; Models, Theoretical

المؤلفون: Elfakhri KH; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Niu M; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Ghosh P; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Ramezanli T; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Raney SG; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Kamal N; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Ashraf M; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Zidan AS; Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Electronic address: Ahmed.Zidan@fda.hhs.gov.

المصدر: International journal of pharmaceutics [Int J Pharm] 2024 Mar 25; Vol. 653, pp. 123794. Date of Electronic Publication: 2024 Jan 10.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Elsevier/North-Holland Biomedical Press Country of Publication: Netherlands NLM ID: 7804127 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-3476 (Electronic) Linking ISSN: 03785173 NLM ISO Abbreviation: Int J Pharm Subsets: MEDLINE

مواضيع طبية MeSH: Tretinoin*, Drug Liberation ; Porosity ; Gels/chemistry ; Viscosity

المؤلفون: Iliopoulos F; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, 149 13th Street, Charlestown 02129, MA, USA., Tu D; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, 149 13th Street, Charlestown 02129, MA, USA., Pence IJ; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, 149 13th Street, Charlestown 02129, MA, USA., Li X; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, 149 13th Street, Charlestown 02129, MA, USA., Ghosh P; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring 20993, MD, USA., Luke MC; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring 20993, MD, USA., Raney SG; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring 20993, MD, USA., Rantou E; Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring 20993, MD, USA., Evans CL; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, 149 13th Street, Charlestown 02129, MA, USA. Electronic address: evans.conor@mgh.harvard.edu.

المصدر: Journal of controlled release : official journal of the Controlled Release Society [J Control Release] 2024 Mar; Vol. 367, pp. 864-876. Date of Electronic Publication: 2024 Feb 19.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Elsevier Science Publishers Country of Publication: Netherlands NLM ID: 8607908 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-4995 (Electronic) Linking ISSN: 01683659 NLM ISO Abbreviation: J Control Release Subsets: MEDLINE

مواضيع طبية MeSH: Skin*/metabolism , Nonlinear Optical Microscopy*, Humans ; Therapeutic Equivalency ; Biological Availability ; Administration, Cutaneous ; Drugs, Generic/chemistry

المؤلفون: Senemar S; Division of Pharmaceutical Sciences, Arnold and Marie Schwartz College of Pharmacy, Long Island University, 75 DeKalb Ave., Brooklyn, New York, 11201, USA., Kuzma BA; Division of Pharmaceutical Sciences, Arnold and Marie Schwartz College of Pharmacy, Long Island University, 75 DeKalb Ave., Brooklyn, New York, 11201, USA.; Drug Metabolism and Pharmacokinetics, Vertex Pharmaceuticals, Boston, Massachusetts, USA., Ramezanli T; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Ghosh P; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Raney SG; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA., Rantou E; Division of Biometrics VIII, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA., Stagni G; Division of Pharmaceutical Sciences, Arnold and Marie Schwartz College of Pharmacy, Long Island University, 75 DeKalb Ave., Brooklyn, New York, 11201, USA. gstagni@gmail.com.

المصدر: AAPS PharmSciTech [AAPS PharmSciTech] 2023 Oct 03; Vol. 24 (7), pp. 204. Date of Electronic Publication: 2023 Oct 03.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer Country of Publication: United States NLM ID: 100960111 Publication Model: Electronic Cited Medium: Internet ISSN: 1530-9932 (Electronic) Linking ISSN: 15309932 NLM ISO Abbreviation: AAPS PharmSciTech Subsets: MEDLINE

مواضيع طبية MeSH: Metronidazole*/metabolism , Skin*/metabolism, Rabbits ; Animals ; Therapeutic Equivalency ; Microdialysis/methods ; Drugs, Generic/pharmacokinetics ; Area Under Curve ; Cross-Over Studies

المؤلفون: Tsakalozou E; 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, Maryland, USA., Alam K; 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, Maryland, USA., Ghosh P; Division of Therapeutic Performance I, 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, Inc., Lancaster, California, USA., Polak S; Certara UK, Simcyp Division, Sheffield, UK.; Jagiellonian University Medical College, Krakow, Poland., Fang L; 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, Maryland, USA., Sammeta S; Teva Pharmaceuticals, Salt Lake City, Utah, USA., Zhao P; Bill & Melinda Gates Foundation, Seattle, Washington, USA., Arora S; Certara UK, Simcyp Division, Sheffield, UK.; Janssen Pharmaceutical, Companies of Johnson & Johnson, Beerse, Belgium., Raney SG; Division of Therapeutic Performance I, 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.

المصدر: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2023 May; Vol. 12 (5), pp. 575-584. Date of Electronic Publication: 2022 Dec 01.

نوع المنشور: Journal Article; Review; Research Support, U.S. Gov't, P.H.S.

بيانات الدورية: Publisher: Wiley Country of Publication: United States NLM ID: 101580011 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2163-8306 (Electronic) Linking ISSN: 21638306 NLM ISO Abbreviation: CPT Pharmacometrics Syst Pharmacol Subsets: MEDLINE

مواضيع طبية MeSH: Drugs, Generic* , Research Report*, Humans ; Pharmaceutical Preparations ; Skin ; Therapeutic Equivalency