Non-clinical safety studies for biotechnologically-derived pharmaceuticals: conclusions from an international workshop

被引:3
|
作者
Griffiths, SA [1 ]
Lumley, CE [1 ]
机构
[1] Ctr Med Res Inst, Carshalton SM5 4DS, Surrey, England
来源
HUMAN & EXPERIMENTAL TOXICOLOGY | 1998年 / 17卷 / 02期
关键词
biotechnology; non-clinical; safety evaluation; pharmaceutical;
D O I
10.1191/096032798678908341
中图分类号
R99 [毒物学(毒理学)];
学科分类号
100405 ;
摘要
[No abstract available]
引用
收藏
页码:63 / 83
页数:21
相关论文
共 50 条
  • [1] Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies
    Mustonen, Enni-Kaisa
    Palomaki, Tiina
    Pasanen, Markku
    [J]. REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2017, 90 : 328 - 341
  • [2] Opportunities for in vivo imaging in non-clinical safety studies
    Stephan-Gueldner, M.
    Buergin, H.
    Funk, J.
    Grimm, H. P.
    Sanders, M.
    Zabka, T. S.
    Singer, T.
    Bergstroem, M.
    [J]. TOXICOLOGY LETTERS, 2011, 205 : S24 - S24
  • [3] Safety pharmacology: an essential interface of pharmacology and toxicology in the non-clinical assessment of new pharmaceuticals
    Claude, JR
    Claude, N
    [J]. TOXICOLOGY LETTERS, 2004, 151 (01) : 25 - 28
  • [4] Non-clinical safety studies on biosimilar recombinant human erythropoietin
    Parnham, Michael J.
    Schindler-Horvat, Janice
    Kozlovic, Marija
    [J]. BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY, 2007, 100 (02) : 73 - 83
  • [5] Considerations for non-clinical safety studies of therapeutic peptide vaccines
    Matsumoto, Mineo
    Komatsu, Shinichi
    Tsuchimoto, Mayumi
    Matsui, Hajime
    Watanabe, Kazuto
    Nakamura, Kazuichi
    Amakasu, Kohei
    Ito, Kanako
    Fueki, Osamu
    Sawada, Jun-ichi
    Maki, Kazushige
    Onodera, Hiroshi
    [J]. REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2014, 70 (01) : 254 - 260
  • [6] Perspectives on non-clinical safety evaluation of drug metabolites through the JS']JSOT workshop
    Minagawa, Toshiya
    Nakano, Kenji
    Furuta, Shigeru
    Iwasa, Takashi
    Takekawa, Koji
    Minato, Kouichi
    Koga, Toshihisa
    Sato, Takashi
    Kawashima, Kosuke
    Kurahashi, Yoshikazu
    Onodera, Hiroshi
    Naito, Shinsaku
    Nakamura, Kazuichi
    [J]. JOURNAL OF TOXICOLOGICAL SCIENCES, 2012, 37 (04): : 667 - 673
  • [7] Echocardiography in non-clinical safety studies: adding value, and increasing acceptance and application
    Coatney, Robert W.
    [J]. TOXICOLOGY LETTERS, 2013, 221 : S50 - S51
  • [8] AAV therapies by convection enhanced delivery (CED): What to expect from non-clinical safety studies
    Vats, Srishti
    Bouchard, Amelie
    Foret, Morgan
    Maghezzi, Said
    Galicia, Archival
    Bennamoune, Nehla
    Authier, Simon
    [J]. JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS, 2023, 123
  • [9] Non-Clinical Safety Studies of IMT504, a Unique Non-CpG Oligonucleotide
    Franco, Raul
    Rodriguez, Juan M.
    Elias, Fernanda
    Hernando-Insua, Andres
    Flo, Juan
    Lopez, Ricardo
    Nagle, Carlos
    Lago, Nestor
    Zorzopulos, Jorge
    Horn, David L.
    Montaner, Alejandro D.
    [J]. NUCLEIC ACID THERAPEUTICS, 2014, 24 (04) : 267 - 282
  • [10] Company strategies for designing non-clinical safety evaluation programmes: Results of a CMR international survey
    Griffiths, SA
    [J]. SAFETY EVALUATION OF BIOTECHNOLOGICALLY-DERIVED PHARMACEUTICALS: FACILITATING A SCIENTIFIC APPROACH, 1998, : 17 - 29