Búsqueda de LIBROS DEL AUTOR: sarfaraz k niazi

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  • BIOSIMILARS DEVELOPMENT STRATEGIES
    ebook
    BIOSIMILARS DEVELOPMENT STRATEGIES
    SARFARAZ K. NIAZI
    After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars. However, the development costs remain high, preventing faster entry into markets with more than 200 choices. Analyzing the regulatory filings of all approved biosimilars in the US and EU, a deep an...

    $1,420.00

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  • MRNA THERAPEUTICS
    ebook
    MRNA THERAPEUTICS
    SARFARAZ K. NIAZI
    This book is the most comprehensive and complete treatise on nucleic acid therapeutic products, including mRNA vaccines, their manufacturing, formulations, and testing for safety and efficacy. Details include cGMP-compliant manufacturing and regulatory filing steps. A new concept of “biosimilar” mRNA vaccine is presented to secure fast approval of copies of mRNA vaccines. Proje...

    $1,340.00

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  • THE FUTURE OF PHARMACEUTICALS
    ebook
    THE FUTURE OF PHARMACEUTICALS
    SARFARAZ K. NIAZI
    Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: ...

    $2,700.00

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  • HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS
    ebook
    HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS
    SARFARAZ K. NIAZI
    The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Six, Sterile Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this sixth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent appli...

    $1,320.00

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  • HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS, THIRD EDITION
    ebook
    HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS, THIRD EDITION
    SARFARAZ K. NIAZI
    The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, an...

    $1,320.00

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  • HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS, THIRD EDITION
    ebook
    HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS, THIRD EDITION
    SARFARAZ K. NIAZI
    The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Four, Semisolid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this fourth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent a...

    $1,320.00

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  • HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS
    ebook
    HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS
    SARFARAZ K. NIAZI
    The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Five, Over-the-Counter Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this fifth volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and pa...

    $1,320.00

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  • HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS, THIRD EDITION
    ebook
    HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS, THIRD EDITION
    SARFARAZ K. NIAZI
    The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this third volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent appl...

    $1,320.00

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  • HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS, THIRD EDITION
    ebook
    HANDBOOK OF PHARMACEUTICAL MANUFACTURING FORMULATIONS, THIRD EDITION
    SARFARAZ K. NIAZI
    The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this second volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and ...

    $1,320.00

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  • HANDBOOK OF PREFORMULATION
    ebook
    HANDBOOK OF PREFORMULATION
    SARFARAZ K. NIAZI
    Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct phase of new drug development. Entirely...

    $1,360.00

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  • BIOSIMILARS AND INTERCHANGEABLE BIOLOGICS
    ebook
    BIOSIMILARS AND INTERCHANGEABLE BIOLOGICS
    SARFARAZ K. NIAZI
    What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of ...

    $3,000.00

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  • BIOSIMILARITY
    ebook
    BIOSIMILARITY
    SARFARAZ K. NIAZI
    Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools require...

    $1,420.00

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  • BIOSIMILARS AND INTERCHANGEABLE BIOLOGICS
    ebook
    BIOSIMILARS AND INTERCHANGEABLE BIOLOGICS
    SARFARAZ K. NIAZI
    What’s the Deal with Biosimilars? Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development. Part of a two-volume set that covers varying aspects of ...

    $1,420.00

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  • HANDBOOK OF BIOEQUIVALENCE TESTING
    ebook
    HANDBOOK OF BIOEQUIVALENCE TESTING
    SARFARAZ K. NIAZI
    As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m ...

    $1,320.00

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  • BIOSIMILARS AND INTERCHANGEABLE BIOLOGICS
    ebook
    BIOSIMILARS AND INTERCHANGEABLE BIOLOGICS
    SARFARAZ K. NIAZI
    This new edition explores the strategic planning side of biosimilar drugs and targets the issues surrounding biosimilars that are linked to legal matters. This includes an examination of new regulatory requirements in terms of principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. Biosimilars and Interchangeable Bio...

    $5,500.00

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