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    حصريا وفي كل المنتديات كتب عن صناعه الادويه متجدد

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    عدد المساهمات : 1204
    تاريخ التسجيل : 28/10/2009
    العمر : 41

    حصريا وفي كل المنتديات كتب عن صناعه الادويه متجدد

    مُساهمة من طرف d-forum في 08/11/09, 09:08 pm

    Cell Therapy: cGMP Facilities and Manufacturing




    Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library.

    Additional topics in Cell Therapy: cGMP Facilities and Manufacturing…

    Standard operating procedures
    Supply management
    Facility equipment
    Product manufacturing, review, release and administration
    Facility master file
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    عدل سابقا من قبل ابو ليندا في 08/11/09, 09:15 pm عدل 1 مرات



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    رد: حصريا وفي كل المنتديات كتب عن صناعه الادويه متجدد

    مُساهمة من طرف d-forum في 08/11/09, 09:09 pm

    Filtration in the Biopharmaceutical Industry

    This timely resource offers comprehensive examinations of the most recent developments in the field, from prefiltration methods to final, gas, and tangential flow filtration techniques. Delineates filtration in a host of applications, including virus removal, protein binding, and sterility testing and introduces new, membrane-based technologies for the biopharmaceutical industry! Addressing quality, security, economic, process development, and regulatory topics, Filtration in the Biopharmaceutical Industry presents pre- and sterility grade filters, charge-modified filter media, and aids to filtration discusses filter quality assurance, pore size, extractables, and compatibilities in various filters examines filter design and construction analyzes integrity testing, test sensitivity, and automation furnishes novel filtration flow methods explains filter validation summarizes the U.S. Food and Drug Administration regulations governing filtration and more!
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    مشرف عام المنتدى

    عدد المساهمات : 1204
    تاريخ التسجيل : 28/10/2009
    العمر : 41

    رد: حصريا وفي كل المنتديات كتب عن صناعه الادويه متجدد

    مُساهمة من طرف d-forum في 08/11/09, 09:12 pm

    Pharmaceutical Dosage Forms: Parenteral Medication (Volume 3)
    \Product Details

    * Hardcover: 572 pages
    * Publisher: Marcel Dekker; 2 edition (January 15, 1993)
    * Language: English
    * ISBN-10: 0824790200
    * ISBN-13: 978-0824790202
    * Product Dimensions: 10 x 7.2 x 1.3 inches
    * Shipping Weight: 2.3 pounds (View shipping rates and policies)
    * Average Customer Review: No customer reviews yet. Be the first.
    * Amazon.com Sales Rank: #2,458,339 in Books


    Review

    . . .a valuable compilation of the current situation in regulatory issues as well as some of the technical problems associated with parenteral drug production.
    ---Pharmaceutical Technology



    Product Description

    University of Tennessee, Memphis. Third and final volume of the second edition of an in-depth text on parenteral medications, for graduate and undergraduate students, and industrial or hospital pharmacists. 17 U.S. contributors. DNLM: Infusions, Parenteral
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    عدد المساهمات : 1204
    تاريخ التسجيل : 28/10/2009
    العمر : 41

    رد: حصريا وفي كل المنتديات كتب عن صناعه الادويه متجدد

    مُساهمة من طرف d-forum في 08/11/09, 09:13 pm

    Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products (Volume 3 of 6

    Product Details

    * Hardcover: 320 pages
    * Publisher: Informa HealthCare; 1 edition (April 26, 2004)
    * Language: English
    * ISBN-10: 0849317487
    * ISBN-13: 978-0849317484
    * Product Dimensions: 11.4 x 8.4 x 0.8 inches
    * Shipping Weight: 2 pounds
    * Average Customer Review: No customer reviews yet. Be the first.
    * Amazon.com Sales Rank: #2,179,384 in Books


    Product Description

    The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and other fluid preparations from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing liquid drugs, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, global manufacturing practices and guidelines, compliance program guidance manual for FDA staff covering drug manufacturing inspections program, waiver of in vivo bioavailability studies for immediate release solid drugs based on a biopharmaceutics classification, in addition to providing quick tips on resolving the common problems in formulating uncompressed drugs
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      الوقت/التاريخ الآن هو 09/12/16, 11:37 am