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  • Biotechnology Operations

    Principles and Practices, Second Edition

    This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are ... Leer más

    $224.99 USD

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  • Demystify Pharma. Vol1: An Introduction To A Typical Pharma Company

    The pharma industry and its constituent companies have been enigmatic and mysterious for the general public. Any student or professional who desires to build a career in the pharma industry have found themselves struggling to understand how the pharma companies actually work and how can they best integrate themselves in these companies to build a solid, long-term, rewarding career. Difficulty in ... Leer más

    $9.99 USD o gratis con Kobo Plus

  • Real World Drug Discovery

    A Chemist's Guide to Biotech and Pharmaceutical Research

    Drug discovery increasingly requires a common understanding by researchers of the many and diverse factors that go into the making of new medicines. The scientist entering the field will immediately face important issues for which his education may not have prepared him: project teams, patent law, consultants, target product profiles, industry trends, Gantt charts, target validation, ... Leer más

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  • Early Drug Development

    Strategies and Routes to First-in-Human Trials

    Edición de Mitchell N. Cayen ...
    The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their ... Leer más

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  • Quality and Safety in Pharmacy Practice

    Gain a complete understanding of the principles of quality improvement and their application to present and future pharmacy practice"This is a nice introduction to the concepts of continuous quality improvement. It is a comfortable read and is written at an elementary level in comparison to other textbooks in the pharmacy curriculum. This may be necessary, since the authors rightly conclude there ... Leer más

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  • A Clinical Trials Manual From The Duke Clinical Research Institute

    Lessons from a Horse Named Jim

    "The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient ... Leer más

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  • Pharmaceutical Lifecycle Management

    Making the Most of Each and Every Brand

    A comprehensive guide to optimizing the lifecycle management of pharmaceutical brandsThe mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create ... Leer más

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  • Principles and Practice of Pharmaceutical Medicine

    The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, ... Leer más

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  • The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

    de John Geigert ...
    This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published ... Leer más

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  • Global New Drug Development

    An Introduction

    Series series ULLA Series in Pharmaceutical Sciences
    The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of ... Leer más

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  • Value Creation in the Pharmaceutical Industry

    The Critical Path to Innovation

    This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation.A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as ... Leer más

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  • Clinical Trials

    What Patients and Healthy Volunteers Need to Know

    Every year, hundreds of thousands of healthy volunteers and patients worldwide undertake the journey through the maze that can be clinical trials. Research participants take part in clinical trials for a variety of reasons. The healthy volunteers may be seeking extra money to pay off college tuition, or they may know someone who is suffering and would potentially benefit from the results of the ... Leer más

    $18.99 USD