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Wyświetlanie 1-19 z 19
Tytuł :
Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs.
Autorzy :
Wu F; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. .; Division of Quantitative Methods and Modeling, Office of Research and Standard, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. .
Shah H; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Li M; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Duan P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Zhao P; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.; Bill & Melinda Gates Foundation, Seattle, Washington, 98109, USA.
Suarez S; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Raines K; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Zhao Y; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Wang M; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.; Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Lin HP; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Duan J; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Yu L; Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Seo P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. .
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Źródło :
The AAPS journal [AAPS J] 2021 Feb 22; Vol. 23 (2), pp. 31. Date of Electronic Publication: 2021 Feb 22.
Typ publikacji :
Journal Article; Research Support, U.S. Gov't, Non-P.H.S.
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 :
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 :
Using a Physiologically Based Pharmacokinetic Absorption Model to Establish Dissolution Bioequivalence Safe Space for Oseltamivir in Adult and Pediatric Populations.
Autorzy :
Miao 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, Maryland, 20993, USA.
Mousa YM; 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, 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, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Raines K; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA.
Seo P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. 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, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, USA. .
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Źródło :
The AAPS journal [AAPS J] 2020 Aug 10; Vol. 22 (5), pp. 107. Date of Electronic Publication: 2020 Aug 10.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, Non-P.H.S.
MeSH Terms :
Models, Theoretical*
Antiviral Agents/*pharmacokinetics
Oseltamivir/*pharmacokinetics
Absorption, Physiological ; Adult ; Child ; Humans ; Therapeutic Equivalency
Czasopismo naukowe
Tytuł :
Dissolution Testing in Drug Product Development: Workshop Summary Report.
Autorzy :
Abend A; Pharmaceutical Sciences, Merck & Co., Inc., West Point, Pennsylvania, 19486, USA. .
Curran D; Analytical Sciences and Development, GlaxoSmithKline, King of Prussia, Pennsylvania, 19406, USA.
Kuiper J; Pharmaceutical Sciences, Merck & Co., Inc., West Point, Pennsylvania, 19486, USA.
Lu X; Drug Product Science and Technology, Bristol Myers Squibb Company, New Brunswick, New Jersey, 08903, USA.
Li H; Vertex Pharmaceuticals Inc., 50 Northern Ave., Boston, Massachusetts, 02210, USA.
Hermans A; Pharmaceutical Sciences, Merck & Co., Inc., West Point, Pennsylvania, 19486, USA.
Kotwal P; Pharmaceutical Sciences, Merck & Co., Inc., West Point, Pennsylvania, 19486, USA.
Diaz DA; Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc., Eastern Point Road, Groton, Connecticut, 06340, USA.
Cohen MJ; Worldwide Research and Development, Global Chemistry and Manufacturing Controls, Pfizer Inc., Eastern Point Road, Groton, Connecticut, 06340, USA.
Zhang L; Drug Product Science and Technology, Bristol Myers Squibb Company, New Brunswick, New Jersey, 08903, USA.
Stippler E; United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Maryland, 20852, USA.
Drazer G; Department of Mechanical and Aerospace Engineering, Rutgers, The State University of New Jersey, New Brunswick, New Jersey, USA.
Lin Y; Analytical Development, Biogen Inc., Cambridge, Massachusetts, 02142, USA.
Raines K; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Yu L; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Coutant CA; Small Molecule Design & Development, Eli Lilly & Co., Lilly Corporate Center, Indianapolis, Indiana, 46285, USA.
Grady H; Takeda Pharmaceutical International, 35 Lansdowne Street, Cambridge, Massachusetts, 02139, USA.
Krämer J; Eurofins-PHAST GmbH, Kardinal-Wendel-Str. 16, 66424, Homburg, Saarland, Germany.
Pope-Miksinski S; AstraZeneca Pharmaceuticals, One MedImmune Way, Gaithersburg, Maryland, 20878, USA.
Suarez-Sharp S; Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
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Źródło :
The AAPS journal [AAPS J] 2019 Jan 28; Vol. 21 (2), pp. 21. Date of Electronic Publication: 2019 Jan 28.
Typ publikacji :
Journal Article
MeSH Terms :
Quality Control*
Drug Development/*methods
Animals ; Congresses as Topic ; Drug Development/standards ; Humans ; Solubility
Czasopismo naukowe
Tytuł :
Applications of Clinically Relevant Dissolution Testing: Workshop Summary Report.
Autorzy :
Suarez-Sharp S; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. .
Cohen M; Pfizer Inc, Eastern Point Road, Groton, Connecticut, 06340, USA.
Kesisoglou F; Pharmaceutical Sciences, Merck & Co., Inc., 770 Sumneytown Pike, West Point, Pennsylvania, 19486, USA.
Abend A; Pharmaceutical Sciences, Merck & Co., Inc., 770 Sumneytown Pike, West Point, Pennsylvania, 19486, USA.
Marroum P; Abbvie, Inc., 1 North Waukegan Road North, Chicago, Illinois, 60064, USA.
Delvadia P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Kotzagiorgis E; Human Medicines Research and Development Support Division, Specialized Disciplines Department, European Medicines Agency - EMA, 30 Churchill Place, London, E14 5EU, UK.
Li M; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Nordmark A; Department of Efficacy and Safety 2, Medical Products Agency-MPA, Uppsala, Sweden.
Bandi N; Pharmaceutical Sciences, Merck & Co., Inc., 770 Sumneytown Pike, West Point, Pennsylvania, 19486, USA.
Sjögren E; Department of Pharmacy, Uppsala University, Box 580, 751 23, Uppsala, Sweden.; Pharmetheus, 752 37, Uppsala, Sweden.
Babiskin A; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Food and Drug Administration, Silver Spring, Maryland, USA.
Heimbach T; Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey, 07936, USA.
Kijima S; Advanced Review with Electronic Data Promotion Group, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.
Mandula H; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Raines K; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Seo P; Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Zhang X; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
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Źródło :
The AAPS journal [AAPS J] 2018 Aug 27; Vol. 20 (6), pp. 93. Date of Electronic Publication: 2018 Aug 27.
Typ publikacji :
Journal Article
MeSH Terms :
Congresses as Topic*
Drug Development*
Drug Liberation*
Chemistry, Pharmaceutical/*methods
Pharmaceutical Research/*methods
Computer Simulation ; Models, Biological ; Solubility
Czasopismo naukowe
Tytuł :
Making Dreams, Not Babies: The Power of Hope in a Teen Family Planning Clinic.
Autorzy :
Raines K
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Źródło :
Creative nursing [Creat Nurs] 2018 Apr 01; Vol. 24 (1), pp. 142-145.
Typ publikacji :
Journal Article
Czasopismo naukowe
Tytuł :
Impact of the US FDA "Biopharmaceutics Classification System" (BCS) Guidance on Global Drug Development.
Autorzy :
Mehta MU; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Uppoor RS; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Conner DP; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Seo P; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Vaidyanathan J; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Volpe DA; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Stier E; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Chilukuri D; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Dorantes A; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Ghosh T; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Mandula H; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Raines K; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Dhanormchitphong P; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Woodcock J; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
Yu LX; Center of Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland 20993, United States.
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Źródło :
Molecular pharmaceutics [Mol Pharm] 2017 Dec 04; Vol. 14 (12), pp. 4334-4338. Date of Electronic Publication: 2017 Nov 07.
Typ publikacji :
Journal Article
MeSH Terms :
Drug Approval*
Biopharmaceutics/*standards
Drug Industry/*standards
Drugs, Generic/*pharmacokinetics
Biological Availability ; Biopharmaceutics/legislation & jurisprudence ; Clinical Trials as Topic/economics ; Clinical Trials as Topic/standards ; Cost Savings ; Drug Industry/economics ; Drug Industry/legislation & jurisprudence ; Drugs, Generic/classification ; Drugs, Generic/economics ; Guidelines as Topic ; Humans ; Intestinal Absorption/physiology ; Permeability ; Solubility ; Therapeutic Equivalency ; United States ; United States Food and Drug Administration/legislation & jurisprudence ; United States Food and Drug Administration/standards
Czasopismo naukowe
Tytuł :
The Effect of Chlorhexidine Bathing on Rates of Nosocomial Infections Among the Critically Ill Population: An Analysis of Current Clinical Research and Recommendations for Practice.
Autorzy :
Raines K; Kimberly Raines, AGACNP-BC, MSN, BSN, RN, CCRN, is a medical critical care fellow at the Carolina Healthcare System, Charlotte, North Carolina, and School of Nursing, University of Pennsylvania, Philadelphia. Kelsey Rosen, AGACNP-BC, MSN, BSN, RN, is a trauma surgery and critical care medicine fellow at the George Washington University Hospital, and School of Nursing, University of Pennsylvania, Philadelphia.
Rosen K
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Źródło :
Dimensions of critical care nursing : DCCN [Dimens Crit Care Nurs] 2016 Mar-Apr; Vol. 35 (2), pp. 84-91.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Baths*
Anti-Infective Agents, Local/*therapeutic use
Chlorhexidine/*therapeutic use
Cross Infection/*prevention & control
Critical Illness ; Humans
Czasopismo naukowe
Tytuł :
Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA.
Autorzy :
Liu Q; US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Generic Drugs, Rockville, Maryland 20855, USA. />Davit BM
Cherstniakova SA
Dandamudi S
Walters JF
Lee CH
Raines KW
Ren K
Williamson LN
Conner DP
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Źródło :
The AAPS journal [AAPS J] 2012 Mar; Vol. 14 (1), pp. 19-22. Date of Electronic Publication: 2011 Dec 01.
Typ publikacji :
Journal Article
MeSH Terms :
United States Food and Drug Administration*
Drug Approval/*statistics & numerical data
Drugs, Generic/*standards
Documentation/standards ; Drugs, Generic/pharmacokinetics ; Humans ; Therapeutic Equivalency ; United States
Czasopismo naukowe
Tytuł :
Using the "write" resources: nursing student evaluation of an interdisciplinary collaboration using a professional writing assignment.
Autorzy :
McMillan LR; Aubum University School of Nursing, Aubum University, Alabama 36849, USA. />Raines K
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Źródło :
The Journal of nursing education [J Nurs Educ] 2011 Dec; Vol. 50 (12), pp. 697-702. Date of Electronic Publication: 2011 Sep 30.
Typ publikacji :
Journal Article
MeSH Terms :
Education, Nursing, Baccalaureate*
Interdisciplinary Communication*
Interpersonal Relations*
Writing*
Adult ; Female ; Humans ; Librarians ; Male ; Mentors ; Peer Review ; Program Evaluation ; Southeastern United States
Czasopismo naukowe
Tytuł :
Headed in the "write" direction: nursing student publication and health promotion in the community.
Autorzy :
McMillan LR; Auburn University School of Nursing, Auburn, Alabama, USA. />Raines K
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Źródło :
The Journal of nursing education [J Nurs Educ] 2010 Jul; Vol. 49 (7), pp. 418-21. Date of Electronic Publication: 2010 Apr 30.
Typ publikacji :
Journal Article
MeSH Terms :
Newspapers as Topic*
Writing*/standards
Community Health Nursing/*education
Education, Nursing, Baccalaureate/*organization & administration
Health Promotion/*organization & administration
Publishing/*organization & administration
Adult ; Alabama ; Attitude of Health Personnel ; Creativity ; Female ; Guidelines as Topic ; Humans ; Male ; Professional Competence ; Students, Nursing/psychology
Czasopismo naukowe
Tytuł :
Making dreams, not babies: the power of hope in a teen family planning clinic.
Autorzy :
Raines K; Auburn University School of Nursing, Auburn, Alabama, USA.
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Źródło :
Creative nursing [Creat Nurs] 2009; Vol. 15 (3), pp. 117-20.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Attitude to Health*
Family Planning Services*/education
Family Planning Services*/organization & administration
Goals*
Psychology, Adolescent*
Pregnancy in Adolescence/*prevention & control
Adolescent ; Alabama ; Choice Behavior ; Female ; Forecasting ; Happiness ; Humans ; Income ; Morale ; Nurse Practitioners/organization & administration ; Nurse Practitioners/psychology ; Nursing Assessment ; Poverty/psychology ; Power, Psychological ; Pregnancy ; Pregnancy in Adolescence/psychology ; Pregnancy in Adolescence/statistics & numerical data ; United States
Czasopismo naukowe
Tytuł :
Protective role of Bacillus anthracis exosporium in macrophage-mediated killing by nitric oxide.
Autorzy :
Weaver J; Center for Vaccine Development, Department of Medicine, University of Maryland School of Medicine, 685 W. Baltimore Street, Baltimore, MD 21201, USA.
Kang TJ
Raines KW
Cao GL
Hibbs S
Tsai P
Baillie L
Rosen GM
Cross AS
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Źródło :
Infection and immunity [Infect Immun] 2007 Aug; Vol. 75 (8), pp. 3894-901. Date of Electronic Publication: 2007 May 14.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural
MeSH Terms :
Microbial Viability*
Anti-Bacterial Agents/*immunology
Bacillus anthracis/*immunology
Macrophages, Peritoneal/*microbiology
Nitric Oxide/*metabolism
Animals ; Anti-Bacterial Agents/metabolism ; Anti-Bacterial Agents/pharmacology ; Cells, Cultured ; Macrophages, Peritoneal/metabolism ; Mice ; Peroxynitrous Acid/metabolism ; Peroxynitrous Acid/pharmacology ; Reactive Oxygen Species/metabolism ; Spores, Bacterial/enzymology ; Spores, Bacterial/physiology
Czasopismo naukowe
Tytuł :
Nitric oxide cell signaling: S-nitrosation of Ras superfamily GTPases.
Autorzy :
Raines KW; Department of Biochemistry and Biophysics, University of North Carolina, 530 Mary Ellen Jones Building, Chapel Hill, NC 27599-7260, USA.
Bonini MG
Campbell SL
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Źródło :
Cardiovascular research [Cardiovasc Res] 2007 Jul 15; Vol. 75 (2), pp. 229-39. Date of Electronic Publication: 2007 Apr 24.
Typ publikacji :
Journal Article; Review
MeSH Terms :
Endothelial Cells/*metabolism
GTP Phosphohydrolases/*metabolism
Nitric Oxide/*metabolism
Signal Transduction/*physiology
Animals ; Cysteine/metabolism ; Humans ; Nitrosation ; Oxidation-Reduction
Czasopismo naukowe
Tytuł :
Redox regulation of RhoA.
Autorzy :
Heo J; Department of Biochemistry and Biophysics, The University of North Carolina, 530 Mary Ellen Jones Building, Chapel Hill, North Carolina 27599-7260, USA.
Raines KW
Mocanu V
Campbell SL
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Źródło :
Biochemistry [Biochemistry] 2006 Dec 05; Vol. 45 (48), pp. 14481-9.
Typ publikacji :
Journal Article
MeSH Terms :
rhoA GTP-Binding Protein/*chemistry
rhoA GTP-Binding Protein/*metabolism
Amino Acid Sequence ; Catalysis ; Cisplatin/pharmacology ; Guanine Nucleotides/metabolism ; Kinetics ; Mass Spectrometry ; Molecular Sequence Data ; Mutation/genetics ; Nitric Oxide/chemistry ; Nitric Oxide/metabolism ; Oxidation-Reduction/drug effects ; Protein Binding ; rhoA GTP-Binding Protein/genetics
Czasopismo naukowe
Tytuł :
Neuronal nitric oxide synthase-induced S-nitrosylation of H-Ras inhibits calcium ionophore-mediated extracellular-signal-regulated kinase activity.
Autorzy :
Raines KW; Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA.
Cao GL
Lee EK
Rosen GM
Shapiro P
Pokaż więcej
Źródło :
The Biochemical journal [Biochem J] 2006 Jul 15; Vol. 397 (2), pp. 329-36.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural
MeSH Terms :
Calcium/*pharmacology
Extracellular Signal-Regulated MAP Kinases/*metabolism
Nitric Oxide Synthase Type I/*physiology
Proto-Oncogene Proteins p21(ras)/*metabolism
Apoptosis ; Cell Line ; Humans ; Ionophores/pharmacology ; Mitogen-Activated Protein Kinase 1/metabolism ; Mitogen-Activated Protein Kinase 3/metabolism ; Models, Biological ; Nitric Oxide/metabolism ; Nitric Oxide Synthase Type I/metabolism ; Proto-Oncogene Proteins c-raf/metabolism ; Signal Transduction
Czasopismo naukowe
Tytuł :
Importance of nitric oxide synthase in the control of infection by Bacillus anthracis.
Autorzy :
Raines KW; Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, 725 West Lombard Street, Baltimore, MD 21201, USA.
Kang TJ
Hibbs S
Cao GL
Weaver J
Tsai P
Baillie L
Cross AS
Rosen GM
Pokaż więcej
Źródło :
Infection and immunity [Infect Immun] 2006 Apr; Vol. 74 (4), pp. 2268-76.
Typ publikacji :
Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
MeSH Terms :
Anthrax/*enzymology
Anthrax/*microbiology
Bacillus anthracis/*pathogenicity
Macrophages/*enzymology
Nitric Oxide Synthase Type II/*physiology
Animals ; Arginase/metabolism ; Bacillus anthracis/ultrastructure ; Cell Line ; Enzyme Induction/genetics ; Isoenzymes/biosynthesis ; Isoenzymes/genetics ; Isoenzymes/physiology ; Macrophages/microbiology ; Macrophages/ultrastructure ; Mice ; Nitric Oxide/biosynthesis ; Nitric Oxide/metabolism ; Nitric Oxide Synthase Type II/biosynthesis ; Nitric Oxide Synthase Type II/genetics ; Phagocytosis/physiology ; Spores, Bacterial/physiology ; Substrate Specificity/genetics
Czasopismo naukowe
Tytuł :
Nitric oxide inhibition of ERK1/2 activity in cells expressing neuronal nitric-oxide synthase.
Autorzy :
Raines KW; Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA.
Cao GL
Porsuphatana S
Tsai P
Rosen GM
Shapiro P
Pokaż więcej
Źródło :
The Journal of biological chemistry [J Biol Chem] 2004 Feb 06; Vol. 279 (6), pp. 3933-40. Date of Electronic Publication: 2003 Nov 05.
Typ publikacji :
Journal Article; Research Support, U.S. Gov't, P.H.S.
MeSH Terms :
Mitogen-Activated Protein Kinase 1/*antagonists & inhibitors
Mitogen-Activated Protein Kinases/*antagonists & inhibitors
Nitric Oxide/*metabolism
Nitric Oxide Synthase/*metabolism
Arginine/pharmacology ; Cell Line ; Electron Spin Resonance Spectroscopy ; Enzyme Inhibitors/metabolism ; Humans ; MAP Kinase Signaling System ; Mitogen-Activated Protein Kinase 3 ; Models, Biological ; Nitric Oxide/biosynthesis ; Nitric Oxide Synthase/genetics ; Nitric Oxide Synthase Type I ; Recombinant Proteins/genetics ; Recombinant Proteins/metabolism ; Superoxides/metabolism ; Transfection
Czasopismo naukowe
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