소장자료

Safety Evaluation of Biotechnologically-derived Pharmaceuticals Facilitating a Scientific Approach [electronic resource] :

  • Griffiths, Susan A. editor. , Lumley, Cyndy E. editor.
  • 1998
Safety Evaluation of Biotechnologically-derived Pharmaceuticals Facilitating a Scientific Approach [electronic resource] :
  • 자료유형
    단행본
  • 서명/저자사항
    Safety Evaluation of Biotechnologically-derived Pharmaceuticals[electronic resource] :Facilitating a Scientific Approach / edited by Susan A. Griffiths, Cyndy E. Lumley.
  • 개인저자
    Griffiths, Susan A., editor., Lumley, Cyndy E., editor.
  • 단체저자
    SpringerLink (Online service)
  • 형태사항
    XVIII, 200 p. : online resource.
  • 총서명
    CMR International Workshop Series
  • 내용주기
    1 Designing non-clinical safety evaluation programmes: The view of the clinician -- 2 Designing non-clinical safety evaluation programmes: The view of the toxicologist -- 3 Company strategies for designing non-clinical safety evaluation programmes: Results of a CMR International survey -- 4 Influence of regulatory systems: A viewpoint of the US FDA process -- 5 Influence of regulatory systems: The European CPMP perspective -- 6 Biotechnologically-derived pharmaceuticals in Japan: Present and future prospects -- 7 Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors and hormones: A personal view -- 8 Designing non-clinical safety evaluation programmes for interferons and interleukins: A personal view -- 9 Designing non-clinical safety evaluation programmes for monoclonal antibodies for therapeutic use: A personal view -- 10 Designing non-clinical safety evaluation programmes for gene therapy products: A personal view -- 11 Recommendations and the way forward -- 12 Designing non-clinical safety evaluation programmes for colony stimulating factors, growth factors and hormones: Recommendations and the way forward -- 13 Designing non-clinical safety evaluation programmes for interferons and interleukins: Past experiences and recommendations for future products -- 14 Designing non-clinical safety evaluation programmes for monoclonal antibodies: Recommendations and the way forward -- 15 Designing a safety evaluation programme for gene therapy products: Recommendations and the way forward -- Appendix I: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals: ICH Step 4 Harmonised Tripartite Guideline -- Appendix II: List of Participants.
  • 일반주제명
    Medicine.
    Pharmacology.
    Public health.
    Medical laws and legislation.
    Biomedicine.
    Pharmacology/Toxicology.
    Medical Law.
    Public Health.
  • 기본자료 저록
    Springer eBooks
  • 기타형태 저록
    Printed edition: 9789401060431
  • ISBN
    9789401148764
  • 언어
    영어