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Handbook Of Biogeneric Therapeutic Proteins : Regulatory, Manufacturing, Testing, And Patent Issues
1,560.00 جنيه

Handbook Of Biogeneric Therapeutic Proteins : Regulatory, Manufacturing, Testing, And Patent Issues

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1,560.00 جنيه 

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الأسعار تشمل ضريبة القيمة المضافة  التفاصيل
رقم ال ISBN
9780849329913
الفئات
الكيمياء الحيوية والتقنية الحيوية
الكاتب
Sarfaraz K. Niazi
الناشر
CRC Press Inc
الوصف:

More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulatory wrinkles yet to be ironed out, generic ...

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البائع:
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معلومات المنتج

  •  

    المواصفات

    رقم ال ISBN
    9780849329913
    الفئات
    الكيمياء الحيوية والتقنية الحيوية
    الرقم المميز للسلعة
    2724546106542
    المؤلفين
    الكاتب
    Sarfaraz K. Niazi
    المؤلفين
    الناشر
    CRC Press Inc
    رقم ال ISBN
    9780849329913
    الفئات
    الكيمياء الحيوية والتقنية الحيوية
    الرقم المميز للسلعة
    2724546106542
    المؤلفين
    الكاتب
    Sarfaraz K. Niazi
    المؤلفين
    الناشر
    CRC Press Inc
    معلومات تقنية
    غلاف الكتاب
    غلاف عادي
    اللغات والبلدان
    لغة الكتاب
    الانجليزية
    إقرأ المزيد
  •  

    الوصف:

    More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric

    More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulatory wrinkles yet to be ironed out, generic or similar biological products are soon to become a reality. Handbook of Biogeneric Therapeutic Proteins is the first book to review and analyze the status of biotechnology, regulatory environment, manufacturing methodologies, testing requirements and intellectual property issues. The book provides complete and thorough coverage of the regulatory and technological challenges of developing generic therapeutic proteins and how to prepare detailed regulatory and manufacturing plans and policies. The author includes information on establishing a manufacturing system, securing regulatory approval, and setting up facilities to manufacture raw materials and prepare finished products. He also supplies details about the Chemistry, Manufacturing, and Controls (CMC) section of the FDA's New Drug Application for Biological Products. In brief, the book supplies everything a manufacturer would need to plan the development of biogeneric products and complete the process of regulatory filing. Waiting for the FDA to issue guidelines is a mistake. The scramble to catch up could leave your company way behind in the game. Your organization needs to begin developing and characterizing genetically modified cells now and to complete initial GMP production runs through a CRO to get ready for the newer testing the FDA might impose. Packed with tables and figures that provide speedy access to precise, timely data, including full formulation details on all FDA approved biological product, this book contains a broad range of resource materials about suppliers, manufacturers, and testing facilities. These features combined with the author's hands-on, practical approach give you the edge you need.

    • Handbook Of Biogeneric Therapeutic Proteins : Regulatory, Manufacturing, Testing, And Patent Issues
    • Author: Sarfaraz K. Niazi
    • Publisher: Crc Press Inc.
    • Published: 2002
 

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