Zobrazeno 1 - 10
of 13
pro vyhledávání: '"Bettina Klug"'
Publikováno v:
Bundesgesundheitsblatt-Gesundheitsforschung-Gesundheitsschutz
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
ZusammenfassungEin Jahrhundert lang wurde die Serumtherapie von Seren tierischen Ursprungs und Hyperimmunglobulinen dominiert. Obwohl seit Ende der Achtzigerjahre des letzten Jahrhunderts zahlreiche monoklonale Antikörper (MAB) insbesondere zur Beha
Autor:
Mike Whelan, Richard C. Condit, Robert T. Chen, Sonali Kochhar, Marc Gurwith, Bettina Klug, James S. Robertson, Jean-Louis Excler, Stephen Drew, Patricia E. Fast, David Wood, Denny Kim, Tamala Mallett Moore, Emily R. Smith, Najwa Khuri-Bulos
Publikováno v:
Vaccine
Several live-attenuated viral vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for
Autor:
Sonali Kochhar, Denny Kim, Jean-Louis Excler, Richard C. Condit, James S. Robertson, Stephen Drew, Mike Whelan, David Wood, Patricia E. Fast, Marc Gurwith, Bettina Klug, Najwa Khuri-Bulos, Emily R. Smith, Robert T Chen
Publikováno v:
Vaccine
Several protein vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-r
Autor:
Lisa Marie Mac, Sonali Kochhar, Bettina Klug, Baevin Carbery, Vidisha Singh, Stephen J. Seligman, R. Michael Hendry, John K. Rose, David K. Clarke, Robert T. Chen
Publikováno v:
Vaccine
The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) was formed to evaluate the safety of live, recombinant viral vaccines incorporating genes from heterologous viral and other microbial pathogens in their genome (so-called "
Publikováno v:
Clinical Research and Regulatory Affairs. 32:55-60
Adjuvants have been incorporated into vaccines for decades to improve the immune response to vaccine antigens. In developing new vaccines or simply improving existing vaccines, interest in adjuvants has been growing rapidly, with various types of adj
Autor:
Baevin Carbery, Michael Hendry, Robert T. Chen, Marc Gurwith, Lisa Mac, Richard C. Condit, Stephen J. Seligman, Jean-Louis Excler, Arifa S. Khan, Kenneth I. Berns, Rebecca L. Sheets, Louisa E. Chapman, Anna-Lise Williamson, Najwa Khuri-Bulos, Bettina Klug, James S. Robertson
Publikováno v:
Vaccine. 33(1):73-75
Recombinant viral vectors provide an effective means for heterologous antigen expression in vivo and thus represent promising platforms for developing novel vaccines against human pathogens from Ebola to tuberculosis. An increasing number of candidat
Publikováno v:
Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz. 53:58-62
Advanced therapy medicinal products (ATMPs) are an innovative treatment option. To promote timely access of the innovative medicinal product and to safeguard public health, new elements have been introduced into legislation. A key element of the ATMP
Publikováno v:
Onkopipeline. 2:86-91
Arzneimittel fur neuartige Therapien („advanced therapy medicinal products“, [ATMP]) unterliegen, wie alle anderen Biotechnologie-Arzneimittel, dem zentralisierten Zulassungsverfahren, welches eine einmalige, zentrale wissenschaftliche Bewertung
Publikováno v:
Molecular Vaccines ISBN: 9783319009773
The European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines; depending on the nature of the product, three different routes of application are possible. For innovative in particular recombina
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::7e2b50a1b887af3a961a4464ab657cee
https://doi.org/10.1007/978-3-319-00978-0_28
https://doi.org/10.1007/978-3-319-00978-0_28
Publikováno v:
Methods in enzymology. 507
Taking into account the complexity and technical specificity of advanced therapy medicinal products: (gene and cell therapy medicinal products and tissue engineered products), a dedicated European regulatory framework was needed. Regulation (EC) No.