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Development of Biopharmaceutical Parenteral Dosage Forms (Drugs and the Pharmaceutical Sciences, 85, Band 85) - Hardcover

 
9780824799816: Development of Biopharmaceutical Parenteral Dosage Forms (Drugs and the Pharmaceutical Sciences, 85, Band 85)
Hardcover
ISBN 10: 082479981X ISBN 13: 9780824799816
Verlag: CRC Press Inc, 1997

Inhaltsangabe

This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process.
Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms

  • details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process
  • describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization
  • considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance
  • elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity
  • shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends
  • reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications
  • and more!
    Furnished with helpful references, tables, and drawings, this practical guide is indispensable

    • Die Inhaltsangabe kann sich auf eine andere Ausgabe dieses Titels beziehen.

    Über die Autorin bzw. den Autor

    John A. Bontempo

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    Verlag
    CRC Press Inc
    Erscheinungsdatum
    1997
    Sprache
    Englisch
    ISBN 10 
    082479981X
    ISBN 13 
    9780824799816
    Einband
    Gebundene Ausgabe
    Anzahl der Seiten
    248
    Herausgeber
    Bontempo John A.
    Kontakt zum Hersteller
    Nicht verfügbar
    Verantwortliche Person
    Taylor & Francis Verlag GmbH
    GPSR@taylorandfrancis.com

    Kaufingerstraße 24, 80331 München, Germany
    München
    Deutschland