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    Impurities In Drug Substances: ICH Explained
    Impurities In Drug Substances: ICH Explained
    Impurities In Drug Substances: ICH Explained
    Ebook26 pages9 minutes

    Impurities In Drug Substances: ICH Explained

    By Kiran Nivedh

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    About this ebook

    Impurities in drug substances – ICH explained is a small book created to understand the impurities and how to present them in the dossier without heating your brain! This book is for the people who are studying pharmacy, chemistry, biochemistry, medicine, regulatory scientists and other beginners and professionals in pharmaceuticals.
    This book exclusively concentrates on ICH guideline ICH Q3A – impurities in new drug substances developed by a council consists of USA, Europe and Japan to have harmonized information for submission of common technical document/dossier. This guideline is adopted by various other countries like India, Australia, Canada, Afghanistan, Albania, Algeria and many...
    Rather than saying this as a small book, I would say this piece as instruction and template to write the impurity section in your drug substance dossier. In the future, all the topics covered by the ICH will be published in a much understandable and easy way with which you can quench your thirst on regulatory affairs and on quality.

    LanguageEnglish
    PublisherKiran Nivedh
    Release dateOct 5, 2019
    ISBN9780463960592
    Impurities In Drug Substances: ICH Explained

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    Reviews for Impurities In Drug Substances

    5/5

    3 ratings2 reviews

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    Review must be at least 10 words

    • 5/5
      Its a good start. Hoping to go further. Waiting for the other ich topics
    • 5/5
      Nicely written and informative. Write more books like this.
      Thanks.

    Book preview

    Impurities In Drug Substances - Kiran Nivedh

    Impurities in Drug substances – ICH explained

    Learn:

    • What is impurity

    • Why should we control impurity

    • Understanding impurities

    • Sources of impurities

    • Presentation of impurities in your dossier

    Kiran Nivedh

    Freelance author and technical editor

    knowaboutregulatory@gmail.com

    Sciencewithkiran.blogspot.com

    Understand the ICH Easily!

    About this Book

    Impurities in drug substances – ICH explained is small book created to understand the impurities and how to present them in the dossier without heating your brain! This book is for the people who are studying pharmacy, chemistry, bio-chemistry, medicine, regulatory scientists and other beginners and professionals in pharmaceuticals.

    This book exclusively concentrates on ICH guideline ICH Q3A – impurities in new drug substances developed by a council consists of USA, Europe and Japan to have a harmonized information for

    Enjoying the preview?
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