LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 9 of total 9

Search options

  1. Article ; Online: Safety, pharmacokinetics, and pharmacodynamics of drotrecogin alfa (activated) in children with severe sepsis.

    Weiss, Karen D

    Pediatrics

    2003  Volume 113, Issue 1 Pt 1, Page(s) 134

    MeSH term(s) APACHE ; Adolescent ; Child ; Child, Preschool ; Fibrinolytic Agents/therapeutic use ; Humans ; Infant ; Infant, Newborn ; Protein C/therapeutic use ; Recombinant Proteins/therapeutic use ; Sepsis/drug therapy ; Sepsis/mortality
    Chemical Substances Fibrinolytic Agents ; Protein C ; Recombinant Proteins ; drotrecogin alfa activated (JGH8MYC891)
    Language English
    Publishing date 2003-12-14
    Publishing country United States
    Document type Journal Article ; Comment
    ZDB-ID 207677-9
    ISSN 1098-4275 ; 0031-4005
    ISSN (online) 1098-4275
    ISSN 0031-4005
    DOI 10.1542/peds.113.1.134
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Um IV Zs.131: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 357: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  2. Article ; Online: Judging the safety of aprotinin.

    Rieves, R Dwaine / Weiss, Karen D

    The New England journal of medicine

    2006  Volume 355, Issue 21, Page(s) 2262

    MeSH term(s) Advisory Committees ; Antifibrinolytic Agents/adverse effects ; Aprotinin/adverse effects ; Data Interpretation, Statistical ; Drug Approval ; Humans ; Myocardial Infarction/chemically induced ; Renal Insufficiency/chemically induced ; Research Design ; United States ; United States Food and Drug Administration
    Chemical Substances Antifibrinolytic Agents ; Aprotinin (9087-70-1)
    Language English
    Publishing date 2006-11-23
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Ua VI Zs.34: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  3. Article ; Online: Prevention of surgical-site infections.

    Weiss, Karen D / Osborne, Steven F / Callahan-Lyon, Priscilla

    The New England journal of medicine

    2010  Volume 362, Issue 16, Page(s) 1541–2; author reply 1543–4

    MeSH term(s) Anti-Infective Agents/therapeutic use ; Antisepsis/methods ; Chlorhexidine/therapeutic use ; Fires/prevention & control ; Humans ; Operating Rooms ; Povidone-Iodine/therapeutic use ; Surgical Wound Infection/prevention & control
    Chemical Substances Anti-Infective Agents ; Povidone-Iodine (85H0HZU99M) ; Chlorhexidine (R4KO0DY52L)
    Language English
    Publishing date 2010-04-22
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Ua VI Zs.34: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  4. Article ; Online: Judging the safety of aprotinin.

    Mangano, Dennis T / Rieves, R Dwaine / Weiss, Karen D

    The New England journal of medicine

    2006  Volume 355, Issue 21, Page(s) 2261–2262

    MeSH term(s) Advisory Committees ; Antifibrinolytic Agents/adverse effects ; Aprotinin/adverse effects ; Cardiac Surgical Procedures ; Data Interpretation, Statistical ; Drug Approval ; Humans ; Research Design ; United States ; United States Food and Drug Administration
    Chemical Substances Antifibrinolytic Agents ; Aprotinin (9087-70-1)
    Language English
    Publishing date 2006-11-23
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc066520
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Ua VI Zs.34: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  5. Article: Good clinical practice and the conduct of clinical studies in pediatric oncology.

    Devine, Susan / Dagher, Ramzi N / Weiss, Karen D / Santana, Victor M

    Pediatric clinics of North America

    2007  Volume 55, Issue 1, Page(s) 187–209, xi–xii

    Abstract: This article discusses the principles that guide good clinical practice standards, with particular emphasis on how they to relate to pediatric oncology research and recent efforts at harmonization. The authors review the clinical trials process and the ... ...

    Abstract This article discusses the principles that guide good clinical practice standards, with particular emphasis on how they to relate to pediatric oncology research and recent efforts at harmonization. The authors review the clinical trials process and the roles of the participants, highlighting the pivotal role of the clinical investigator and the research team, and briefly review the historical aspects of drug development regulations in the United States and the current regulatory paths for pediatric oncology drug development. Where relevant, historical events that underlie many of the regulations and their current applications are described, and practical examples are provided.
    MeSH term(s) Biomedical Research/standards ; Clinical Trials as Topic/standards ; Human Experimentation/standards ; Humans ; Informed Consent ; Neoplasms/therapy ; Pediatrics/standards ; Research Design
    Language English
    Publishing date 2007-12-26
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 215711-1
    ISSN 1557-8240 ; 0031-3955
    ISSN (online) 1557-8240
    ISSN 0031-3955
    DOI 10.1016/j.pcl.2007.10.008
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Um IV Zs.147: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  6. Article ; Online: Testing of Adenoviral Vector Gene Transfer Products: FDA Expectations

    Bauer, Steven R. / Pilaro, Anne M. / Weiss, Karen D.

    Adenoviral Vectors for Gene Therapy

    Abstract: This chapter describes the agency requirements and guidelines for drug development of adenoviral-containing products. The Food and Drug Administration (FDA) assessment of safety and ultimately effectiveness of adenovirus containing products involves ... ...

    Abstract This chapter describes the agency requirements and guidelines for drug development of adenoviral-containing products. The Food and Drug Administration (FDA) assessment of safety and ultimately effectiveness of adenovirus containing products involves thorough evaluation of the information contained in the Investigational New Drug Application (IND), and any supporting information cross-referenced to another IND or drug master file. Many factors contribute to development of FDA recommendations and requirements for characterization of adenovirus vectors. The FDA receives input and feedback from a variety of sources in formulating recommendations regarding adenovirus manufacturing and characterization. The recommendations may change with advances in technology and through accumulating experience. FDA considers the potential risks and benefits of each vector product and each proposed clinical trial when making its recommendations. The FDA is cognizant of the need for flexibility in its recommendations and will consider many factors, including the intended target population, the seriousness of the disease under study, the potential benefits and risks from the investigational product, when advising sponsors about their adenovirus development program.
    Keywords covid19
    Publisher PMC
    Document type Article ; Online
    DOI 10.1016/b978-012199504-1/50022-5
    Database COVID19

    Kategorien

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  7. Article: Continuing reassessment of the risks of erythropoiesis-stimulating agents in patients with cancer.

    Juneja, Vinni / Keegan, Patricia / Gootenberg, Joseph E / Rothmann, Mark D / Shen, Yuan Li / Lee, Kyung Y / Weiss, Karen D / Pazdur, Richard

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2008  Volume 14, Issue 11, Page(s) 3242–3247

    Abstract: Purpose: Erythropoiesis-stimulating agents (ESA) are approved for the treatment of anemia in patients with nonmyeloid malignancies whose anemia is due to the effect of concomitantly administered chemotherapy. Since the 1993 approval of epoetin alfa in ... ...

    Abstract Purpose: Erythropoiesis-stimulating agents (ESA) are approved for the treatment of anemia in patients with nonmyeloid malignancies whose anemia is due to the effect of concomitantly administered chemotherapy. Since the 1993 approval of epoetin alfa in patients with cancer, the risk of thrombovascular events, decreased survival, and poorer tumor control have been increasingly recognized. The risks of ESAs in patients with cancer and the design of trials to assess these risks have been the topic of discussion at two Oncologic Drugs Advisory Committees in 2004 and 2007.
    Experimental design: Evaluation of randomized clinical trials comparing use of ESAs to transfusion support alone in patients with active cancer.
    Results: Six studies (Breast Cancer Erythropoeitin Survival Trial, Evaluation of NeoRecormon on outcome in Head And Neck Cancer in Europe, Danish Head and Neck Cancer, Lymphoid Malignancy, CAN-20, and Anemia of Cancer) investigating ESAs in oncology patients showed decreased survival, decreased duration of locoregional tumor control, and/or increased risk of thrombovascular events. In these six studies, ESA dosing was targeted to achieve and maintain hemoglobin values in excess of current recommendations, and in three of the six studies, ESAs were administered to patients not receiving chemotherapy.
    Conclusions: ESAs increase the risk of thrombovascular events and result in decreased survival and poorer tumor control when administered to achieve hemoglobin levels of > or =12 g/dL in patients with nonmyeloid malignancies. No completed or ongoing randomized, controlled trial has addressed safety issues of ESAs in patients with chemotherapy-associated anemia using currently approved dosing regimens in an epidermal tumor type. Additional studies are needed to better characterize these risks.
    MeSH term(s) Anemia/chemically induced ; Anemia/drug therapy ; Antineoplastic Agents/adverse effects ; Blood Transfusion ; Hematinics/adverse effects ; Humans ; Neoplasms/complications ; Neoplasms/drug therapy ; Randomized Controlled Trials as Topic ; Risk Factors
    Chemical Substances Antineoplastic Agents ; Hematinics
    Language English
    Publishing date 2008-06-01
    Publishing country United States
    Document type Journal Article ; Meta-Analysis
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-07-1872
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 4223: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  8. Article ; Online: Chapter 21 Testing of Adenoviral Vector Gene Transfer Products FDA Expectations

    Bauer, Steven R. / Pilaro, Anne M. / Weiss, Karen D.

    Adenoviral Vectors for Gene Therapy

    Abstract: Publisher Summary This chapter describes the agency requirements and guidelines for drug development of adenoviral-containing products. The Food and Drug Administration (FDA) assessment of safety and ultimately effectiveness of adenovirus containing ... ...

    Abstract Publisher Summary This chapter describes the agency requirements and guidelines for drug development of adenoviral-containing products. The Food and Drug Administration (FDA) assessment of safety and ultimately effectiveness of adenovirus containing products involves thorough evaluation of the information contained in the Investigational New Drug Application (IND), and any supporting information cross-referenced to another IND or drug master file. Many factors contribute to development of FDA recommendations and requirements for characterization of adenovirus vectors. The FDA receives input and feedback from a variety of sources in formulating recommendations regarding adenovirus manufacturing and characterization. The recommendations may change with advances in technology and through accumulating experience. FDA considers the potential risks and benefits of each vector product and each proposed clinical trial when making its recommendations. The FDA is cognizant of the need for flexibility in its recommendations and will consider many factors, including the intended target population, the seriousness of the disease under study, the potential benefits and risks from the investigational product, when advising sponsors about their adenovirus development program.
    Keywords covid19
    Publisher Elsevier
    Document type Article ; Online
    DOI 10.1016/b978-012199504-1/50022-5
    Database COVID19

    Kategorien

    Inter-library loan at ZB MED

    Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

  9. Article: U.S. Food and Drug Administration approval: panitumumab for epidermal growth factor receptor-expressing metastatic colorectal carcinoma with progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

    Giusti, Ruthann M / Shastri, Kaushikkumar / Pilaro, Anne M / Fuchs, Chana / Cordoba-Rodriguez, Ruth / Koti, Kallappa / Rothmann, Mark / Men, Angela Yuxin / Zhao, Hong / Hughes, Monica / Keegan, Patricia / Weiss, Karen D / Pazdur, Richard

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2008  Volume 14, Issue 5, Page(s) 1296–1302

    Abstract: Purpose: To describe the Food and Drug Administration review and marketing approval considerations for panitumumab (Vectibix) for the third-line treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal carcinoma.: ... ...

    Abstract Purpose: To describe the Food and Drug Administration review and marketing approval considerations for panitumumab (Vectibix) for the third-line treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal carcinoma.
    Experimental design: Food and Drug Administration reviewed a single, open-label, multicenter trial in which 463 patients with epidermal growth factor receptor-expressing metastatic colorectal cancer who had progressed on or following treatment with a regimen containing a fluoropyrimidine, oxaliplatin, and irinotecan were randomized (1:1) to receive best supportive care (BSC) with or without panitumumab (6 mg/kg every other week) administered until disease progression or intolerable toxicity. Progression and response were confirmed by an independent review committee masked to treatment assignment. At progression, patients in the BSC-alone arm were eligible to receive panitumumab.
    Results: Although median progression-free survival (PFS) was similar in both treatment arms ( approximately 8 weeks), the mean PFS was approximately 50% longer among patients receiving panitumumab than among those receiving BSC alone (96 versus 60 days, respectively) and the objective response rate in patients receiving panitumumab was 8%. However, no difference in overall survival was shown between the two study arms.
    Conclusions: Panitumumab received accelerated approval based on improvement in PFS and an independently confirmed response rate of 8%, similar to that observed with other active agents at this advanced stage of disease. Confirmation of clinical benefit will be required for full approval.
    MeSH term(s) Adult ; Aged ; Antibodies, Monoclonal/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Camptothecin/administration & dosage ; Camptothecin/analogs & derivatives ; Chemotherapy, Adjuvant ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/metabolism ; Colorectal Neoplasms/pathology ; Disease Progression ; Disease-Free Survival ; Drug Approval ; Fluorouracil/administration & dosage ; Humans ; Liver Neoplasms/drug therapy ; Liver Neoplasms/metabolism ; Liver Neoplasms/secondary ; Lung Neoplasms/drug therapy ; Lung Neoplasms/metabolism ; Lung Neoplasms/secondary ; Lymphatic Metastasis ; Male ; Middle Aged ; Organoplatinum Compounds/administration & dosage ; Receptor, Epidermal Growth Factor/metabolism ; Survival Rate ; United States ; United States Food and Drug Administration
    Chemical Substances Antibodies, Monoclonal ; Organoplatinum Compounds ; oxaliplatin (04ZR38536J) ; panitumumab (6A901E312A) ; irinotecan (7673326042) ; Receptor, Epidermal Growth Factor (EC 2.7.10.1) ; Fluorouracil (U3P01618RT) ; Camptothecin (XT3Z54Z28A)
    Language English
    Publishing date 2008-03-01
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-07-1354
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 4223: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

To top