LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 6 of total 6

Search options

  1. Article: Nonclinical toxicology in support of licensure of gene therapies. Arlington, VA, USA, March 13-14, 2003.

    Frederickson, Robert M / Carter, Barrie J / Pilaro, Anne M

    Molecular therapy : the journal of the American Society of Gene Therapy

    2003  Volume 8, Issue 1, Page(s) 8–10

    MeSH term(s) Animals ; Drug Industry ; Gene Transfer Techniques ; Genetic Therapy/legislation & jurisprudence ; Genetic Therapy/methods ; Genetic Vectors ; Humans ; Licensure ; Research ; United States ; United States Food and Drug Administration
    Language English
    Publishing date 2003-07-08
    Publishing country United States
    Document type Congress
    ZDB-ID 2010592-7
    ISSN 1525-0024 ; 1525-0016
    ISSN (online) 1525-0024
    ISSN 1525-0016
    DOI 10.1016/s1525-0016(03)00192-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 5640: 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.

  2. 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.

  3. Article ; Online ; Conference proceedings: ICH guidelines: inception, revision, and implications for drug development.

    Wang, Tao / Jacobson-Kram, David / Pilaro, Anne M / Lapadula, Daniel / Jacobs, Abigail / Brown, Paul / Lipscomb, John / McGuinn, William David

    Toxicological sciences : an official journal of the Society of Toxicology

    2010  Volume 118, Issue 2, Page(s) 356–367

    MeSH term(s) Animals ; Antineoplastic Agents/pharmacology ; Biological Products/toxicity ; Biotechnology/methods ; Drug Design ; Drug Discovery ; Drug-Related Side Effects and Adverse Reactions ; Guidelines as Topic ; Humans ; International Agencies/organization & administration ; International Cooperation ; Mutagenicity Tests ; Reproduction/drug effects
    Chemical Substances Antineoplastic Agents ; Biological Products
    Language English
    Publishing date 2010-12
    Publishing country United States
    Document type Congresses
    ZDB-ID 1420885-4
    ISSN 1096-0929 ; 1096-6080
    ISSN (online) 1096-0929
    ISSN 1096-6080
    DOI 10.1093/toxsci/kfq286
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 1709: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.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.

  4. 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.

  5. 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.

  6. Article: First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer.

    Blumenthal, Gideon M / Scher, Nancy S / Cortazar, Patricia / Chattopadhyay, Somesh / Tang, Shenghui / Song, Pengfei / Liu, Qi / Ringgold, Kimberly / Pilaro, Anne M / Tilley, Amy / King, Kathryn E / Graham, Laurie / Rellahan, Barbara L / Weinberg, Wendy C / Chi, Bo / Thomas, Colleen / Hughes, Patricia / Ibrahim, Amna / Justice, Robert /
    Pazdur, Richard

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

    2013  Volume 19, Issue 18, Page(s) 4911–4916

    Abstract: On June 8, 2012, the U.S. Food and Drug Administration (FDA) approved pertuzumab (Perjeta, Genentech) for use in combination with trastuzumab (Herceptin, Genentech) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer ( ... ...

    Abstract On June 8, 2012, the U.S. Food and Drug Administration (FDA) approved pertuzumab (Perjeta, Genentech) for use in combination with trastuzumab (Herceptin, Genentech) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Approval was based on the results of a randomized, double-blind, placebo-controlled trial conducted in 808 patients with HER2-positive MBC. Patients were randomized (1:1) to receive pertuzumab (n = 402) or placebo (n = 406) in combination with trastuzumab and docetaxel. The primary endpoint was progression-free survival (PFS) and a key secondary endpoint was overall survival (OS). A statistically significant improvement in PFS (difference in medians of 6.1 months) was observed in patients receiving pertuzumab [HR, 0.62; 95% confidence interval (CI), 0.51-0.75; P < 0.0001]. A planned interim analysis suggested an improvement in OS (HR, 0.64; 95% CI, 0.47-0.88; P = 0.0053) but the HR and P value did not cross the stopping boundary. Common adverse reactions (>30%) observed in patients on the pertuzumab arm included diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy. No additive cardiac toxicity was observed. Significant manufacturing issues were identified during the review. On the basis of substantial evidence of efficacy for pertuzumab in MBC and the compelling public health need, FDA did not delay availability to patients pending final resolution of all manufacturing concerns. Therefore, FDA approved pertuzumab but limited its approval to lots not affected by manufacturing problems. The applicant agreed to multiple manufacturing and testing postmarketing commitments under third-party oversight to resolve manufacturing issues.
    MeSH term(s) Antibodies, Monoclonal, Humanized/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Drug Approval ; Female ; Humans ; Neoplasm Metastasis/drug therapy ; Randomized Controlled Trials as Topic ; Receptor, ErbB-2/antagonists & inhibitors ; Receptor, ErbB-2/metabolism ; Taxoids/administration & dosage ; Trastuzumab ; Treatment Outcome ; United States ; United States Food and Drug Administration
    Chemical Substances Antibodies, Monoclonal, Humanized ; Taxoids ; docetaxel (15H5577CQD) ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1) ; pertuzumab (K16AIQ8CTM) ; Trastuzumab (P188ANX8CK)
    Language English
    Publishing date 2013-09-15
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-13-1212
    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