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  1. [41]
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    تاريخ التسجيل: Nov 2008
    المشاركات: 146
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    Pharmaceutical Process Scale-Up
    • Publisher: Informa Healthcare
    • Number Of Pages: 584
    • Publication Date: 2001-12-12
    • ISBN-10 / ASIN: 0824706250
    • ISBN-13 / EAN: 9780824706258
    • Binding: Hardcover
    Product Description:

    Focusing on scientific and practical aspects of process scale-up, this resource details the theory and practice of transferring pharmaceutical processes from laboratory scale to the plant and production scale. It covers parenteral and nonparenterel liquids and semi-solids, products derived from biotechnology, dry blending and powder handling, granulation and drying, fluid bed [COLOR=orange! important][/COLOR]compaction and tableting, and film coating and regulatory requirements for scale-up and postapproval changes. Drawing on the experience of twenty contributing [COLOR=orange! important][/COLOR], the book employs dimensional analysis as a unified scientific approach to quantify similar processes on different scales.
    DOWNLOAD LINK:

    http://rapidshare.com/files/114121199/082474196X.zip
    http://rapidshare.com/files/114548480/Pharma_proc_sclup.zip

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  2. [42]
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    تاريخ التسجيل: Nov 2008
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    Stability of drugs and dosage forms
    • Publisher: Springer
    • Number Of Pages: 272
    • Publication Date: 2000-11
    • Sales Rank: 351264
    • ISBN / ASIN: 0306464047
    • EAN: 9780306464041
    • Binding: Hardcover
    • Manufacturer: Springer
    • Studio: Springer
    • Average Rating:
    • Total Reviews:
    Book Description:
    Drug products are complex mixtures of drugs and excipients and, as such, their chemical and physical stability kinetics are complex. This book discusses the stability of these dosage forms with preformulation studies through to the studies on the final products. The book is intended for graduate students, professionals in the field of Pharmaceutics and [COLOR=orange! important][/COLOR]Chemistry.
    http://rapidshare.com/files/50663431/stability_of_drugs_and_dosage_forms.pdf
    http://rapidshare.com/files/50694531/stability_drugs_dosage_forms.zip

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  3. [43]
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    تاريخ التسجيل: Nov 2008
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    Pharmaceutical Process Validation
    • Publisher: Informa HealthCare
    • Number Of Pages: 776
    • Publication Date: 2003-03-27
    • ISBN-10 / ASIN: 0824708385
    • ISBN-13 / EAN: 9780824708382
    • Binding: Hardcover

    Product Description:

    The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
    DOWNLOAD LINK:
    http://gigapedia.org/redirect.id:8fc...49880d4564.url

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  4. [44]
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    New Drug Approval Process
    • Publisher: Informa HealthCare

    • Number Of Pages: 664
    • Publication Date: 2004-05-21
    • ISBN-10 / ASIN: 0824750411
    • ISBN-13 / EAN: 9780824750411
    • Binding: Hardcover
    Product Description:

    Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals, and medical devices, the Fourth Edition details the specific regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications. It communicates and integrates a new approach to the world of pharmaceutical personnel on all aspects of new product development and alerts readers to clinical and regulatory tasks that require immediate attention and long-term follow-up in order to comply with the international acceptance of new product approvals.


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  5. [45]
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  6. [46]
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    تاريخ التسجيل: Nov 2008
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    Method Validation in Pharmaceutical Analysis
    Publisher: Wiley-VCH
    • Number Of Pages: 418
    • Publication Date: 2005-05-06
    • ISBN-10 / ASIN: 3527312552
    • ISBN-13 / EAN: 9783527312559
    • Binding: Hardcover
    Product Description:

    Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness.
    Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends.
    With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
    http://rapidshare.com/files/73014014/mevaphan.rar
    http://rapidshare.com/files/132529892/Met_vali_pharma.zip

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  7. [47]
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    تاريخ التسجيل: Nov 2008
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    Analytical Method Development and Validation
    • Publisher: CRC

    • Number Of Pages: 96
    • Publication Date: 1997-05-16
    • Sales Rank: 567067
    • ISBN / ASIN: 0824701151
    • EAN: 9780824701154
    • Binding: Paperback
    • Manufacturer: CRC
    • Studio: CRC
    • Average Rating: 3.5
    • Total Reviews: 2

    Book Description:
    Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

    http://rapidshare.com/files/42476639/Analytical_Method_Deve_Vali.zip
    http://rapidshare.com/files/22510504/amdv.rar

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  8. [48]
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    تاريخ التسجيل: Nov 2008
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    HPLC Method Development for Pharmaceuticals (Separation Science and Technology, Volume 8)
    • Publisher: Academic Press
    • Number Of Pages: 532
    • Publication Date: 2007-06-07
    • ISBN-10 / ASIN: 0123705401
    • ISBN-13 / EAN: 9780123705402
    • Binding: Hardcover
    Product Description:

    High pressure, or high performance, liquid chromatography (HPLC) is the method of choice for checking purity of new drug candidates, monitoring changes during scale up or revision of synthetic procedures, evaluating new formulations, and running control/assurance of the final drug product. HPLC Method Development for Pharmaceuticals provides an extensive overview of modern HPLC method development that addresses these unique concerns. Includes a review and update of the current state of the art and science of HPLC, including theory, modes of HPLC, column chemistry, retention mechanisms, chiral separations, modern instrumentation (including ultrahigh-pressure systems), and sample preparation. Emphasis has been placed on implementation in a pharmaceutical setting and on providing a practical perspective.
    HPLC Method Development for Pharmaceuticals is intended to be particularly useful for both novice and experienced HPLC method development chemists in the pharmaceutical industry and for managers who are seeking to update their knowledge.

    * Covers the requirements for HPLC in a pharmaceutical setting including strategies for software and hardware validation to allow for use in a regulated laboratory
    * Provides an overview of the pharmaceutical development process (clinical phases, chemical and pharmaceutical development activities)
    * Discusses how HPLC is used in each phase of pharmaceutical development and how methods are developed to support activities in each phase.


    http://rapidshare.com/files/74086251/Ahu9780123705402.rar
    http://rapidshare.com/files/74149161/HPLC_Method_Develop_Pharma.zip

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  9. [49]
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    تاريخ التسجيل: Nov 2008
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    USP NF 2007 (United States Pharmacopeia/National Formulary)


    • Publisher: Not Avail
    • Number Of Pages:
    • Publication Date: 2007-05
    • Sales Rank: 1105649
    • ISBN / ASIN: 1889788473
    • EAN: 9781889788470
    • Binding: Hardcover
    • Manufacturer: Not Avail
    • Studio: Not Avail
    • Average Rating:
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    the book was created by lawrence as chm file
    The United States Pharmacopeia is a compendium of quality control tests for drugs and excipients to be introduced into a medicinal formulation. It is published every year [1] by the United States Pharmacopoeial Convention. It forms the basis of enforcement actions by the U.S. Food and Drug Administration and the U.S. Drug Enforcement Administration and is the official pharmacopoeia of the U.S.A. and many other nations. Therefore, in case of a dispute, those methods for, amongst others, identification, assay and purity determination of a drug substance or excipient which are stated in the USP will be the legally binding ones.

    Within the field the compendium is referred to simply as the USP. The initials USP are affixed to materials' names to indicate that they conform to the specifications in the USP and may be used medicinally.
    http://rapidshare.com/files/28302024/USP30-NF25_by_w5a.us.rar

    pass: www.w5a.us

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  10. [50]
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    تاريخ التسجيل: Nov 2008
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    Introduction to the Pharmaceutical Regulatory Process (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs)
    • Publisher: Informa HealthCare

    • Number Of Pages: 736
    • Publication Date: 2004-11-16
    • ISBN-10 / ASIN: 0824754646
    • ISBN-13 / EAN: 9780824754648
    • Binding: Hardcover
    Product Description:

    Providing in-depth coverage of the procedures utilized by pharmaceutical companies for regulatory compliance, this reference describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States-standing alone as the only authoritative guide to address the complex web of regulatory requirements, application processes, and quality control issues influencing the pharmaceutical industry.

    http://rapidshare.com/files/18808661/TPRP.rar.html
    http://rapidshare.com/files/43938499/Pharma_Regu_Proce.rar

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