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Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems


This book serves as a comprehensive source to improve understanding of excipients and forge new avenues to promote independent regulatory review and ...

  • CodeCallNoLokasiKetersediaan
    01021060500060Tersedia
  • Perpustakaan
    Fakultas Farmasi
    Judul Seri
    -
    No. Panggil
    615.1-1 Kat E
    Penerbit Informa Healthcare : New York.,
    Deskripsi Fisik
    xvii, 452 hal. Ilus. ; 26 cm Index. Hlm 437 - 452
    Bahasa
    Indonesia
    ISBN/ISSN
    978-0-8493-2706-7
    Klasifikasi
    615.1-1 Kat E
    Tipe Isi
    -
    Tipe Media
    -
    Tipe Pembawa
    -
    Edisi
    NULL
    Subyek
    Info Detil Spesifik
    -
    Pernyataan Tanggungjawab
  • This book serves as a comprehensive source to improve understanding of excipients and forge new avenues to promote independent regulatory review and development of novel excipients. And presents in-depth information on various aspects of excipient development, safety/toxicology testing, regulatory processes, quality, manufacturability, and the utility of excipients for various drug delivery system. The book divided 23 chapters. Chapter 1 discuss excipients: background/introduction. Chapter 2 discuss food and drug administration perspective on regulation of pharmaceutical excipients. Chapter 3 discuss pharmaceutical excipients development preclinical challenge. Chapter 4 discuss regulation of pharmaceutical excipients. Chapter 5 discuss cyclodextrins-enabling excipients: a case study of the development of a new excipient-sulfobutylether ?-cyclodextrin (CAPTISOL). Chapter 6 discuss the use of food additive safety evaluation procedures as a basic for evaluation the safety of new pharmaceutical excipients. Chapter 7 discuss pharmacopeial harmonization. Chapter 8 discuss excipient interaction. Chapter 9 discuss improved excipient functionality by coprocessing. Chapter 10 discuss a comparison of physical and mechanical properties of common tableting diluents. Chapter 11 discuss excipients for oral liquid formulations. Chapter 12 discuss use of nonactive pharmaceutical excipients in oral drug formulations: biopharmaceutical classification system considerations. Chapter 13 discuss excipients for semisolid formulations. Chapter 14 discuss excipients for pulmonary formulations. Chapter 15 discuss synergistic combinations of penetration enhancers and their discovery by high-throughput screening. Chapter 16 discuss excipient selection and criteria for injectable dosage forms. Chapter 17 discuss excipients for protein drugs. Chapter 18 discuss excipients used in vaccines. Chapter 19 discuss polymeric excipients for controlled release applications. Chapter 20 discuss emerging excipients in parenteral medications: the new paradigm. Chapter 21 discuss excipient manufacturing and good manufacturing practices. Chapter 22 discuss excipient quality assurance: handling, sampling, and regulatory issues. Chapetr 23 discuss excipient distribution.
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