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  • Biologicals - World Health Organization (WHO)
    Biologicals are a class of medicines made from living cells taken from plants, animals or bacteria These cells are use in creating many types of health care products, including vaccines This group of medicines also includes products derived from human blood and plasma for the treatment of many life-threatening diseases and for surgical procedures
  • WHO good manufacturing practices for biological products
    Good manufacturing practices (GMP) for biological products were first published by WHO in 1992 (1) This current revision reflects subsequent developments that have taken place in science and technology, and in the application of risk-based approaches to GMP (2–14) The content of this document should be considered complementary to the general recommendations set out in the current WHO good
  • Annex 7 - World Health Organization (WHO)
    1 2 Transfer of technology is defi ned as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites” It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and or commercialization to an
  • Annex 8 - World Health Organization (WHO)
    Background The World Health Organization (WHO) published the first edition of the WHO Guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms in 2006 (1) After a revision, the second edition of the document was published in 2011 (2) Consideration of various comments and questions related to good
  • Annex 6 - World Health Organization (WHO)
    Introduction Following implementation of these WHO good manufacturing practices (GMP) guidelines (1) within the context of the WHO Prequalifi cation of Medicines Programme, clarifying, editorial modifi cations have been proposed These changes were adopted for maintenance purposes In order to ease reading the full guideline has been reproduced again as an Annex to the current report of the
  • International Clinical Trials Registry Platform (ICTRP)
    The mission of the WHO International Clinical Trials Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making This will improve research transparency and will ultimately strengthen the validity and value of the scientific evidence base Registration of all interventional trials is a scientific, ethical and moral
  • Immunization, Vaccines and Biologicals - World Health Organization (WHO)
    The Immunization, Vaccines and Biologicals department is responsible for targeting vaccine-preventable diseases, guiding immunization research and establishing immunization policy
  • Health products policy and standards
    INNs have been assigned to biological products since the early days of the INN Programme As well as many names for individual substances, animal insulin preparations were given an INN in Recommended list 3 in 1959


















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