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  • Industrial Pharmacy -II

    To ensure that the students can understand the concept and contents, the book has been written in a clear language. Each subject has been thoroughly explained. However, certain things that are significant and valuable are covered. This will make it easier for the students to connect their theoretical learning to the real-world needs of the pharmaceutical sector.The course would make all the ... Leer más

    $55.00 USD o gratis con Kobo Plus

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  • Pharmacovigilance Medical Writing

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    Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e ... Leer más

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  • Medical Product Regulatory Affairs

    Pharmaceuticals, Diagnostics, Medical Devices

    Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and ... Leer más

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  • Process Architecture in Biomanufacturing Facility Design

    Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing fieldBiomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical ... Leer más

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  • Clinical Engineering Handbook

    Edición de Joseph Dyro ...
    As the biomedical engineering field expands throughout the world, clinical engineers play an evermore-important role as translators between the medical, engineering, and business professions. They influence procedure and policy at research facilities, universities, as well as private and government agencies including the Food and Drug Administration and the World Health Organization. The ... Leer más

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  • Generic Drugs

    A Consumer’S Self-Defense Guide

    When you purchase drug products, you dont expect them to be contaminated with antifreeze, industrial chemicals, glass, or dangerous bacteria. But this happens every day when uninformed consumers buy prescription or over-the- counter and behind-the-counter drug products.Armed with the right knowledge, you can avoid the dangers and risks of these drugs and protect yourself and your family. This ... Leer más

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  • Good Design Practices for GMP Pharmaceutical Facilities

    Edición de Terry Jacobs ...
    Series series Drugs and the Pharmaceutical Sciences
    This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical ... Leer más

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  • The Survival Guide to EU Medical Device Regulations

    The Regulations for medical devices and in vitro diagnostic medical devices were published in the Official Journal of the European Union on 5 May 2017, and they entered into force 26 May 2017. A regulation is a legal act of the European Union that becomes immediately enforceable as law in all Member States simultaneously. This book gives guidance on the definitions, the key concepts and the main ... Leer más

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  • Medical Device

    A Primer Based on Best Practices

    de Rommel Garcia ...
    This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who ... Leer más

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  • How to Validate a Pharmaceutical Process

    Series series Expertise in Pharmaceutical Process Technology
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  • Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

    Series Libro 4 - Wiley Series in Biotechnology and Bioengineering
    Sets forth tested and proven risk management practices in drug manufacturingRisk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management ... Leer más

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  • Pharmaceutical Quality by Design

    A Practical Approach

    Series series Advances in Pharmaceutical Technology
    A practical guide to Quality by Design for pharmaceutical product developmentPharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative ... Leer más

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