Medical Writing in Drug Development: A Practical Guide for Pharmaceutical Research
Average customer rating: 3 out of 5 stars
  • Useful for a newcomer to the clinical trial environment
  • Not a practical guide, more a manifesto !
Medical Writing in Drug Development: A Practical Guide for Pharmaceutical Research
ROBERT J. BONK
Manufacturer: Haworth Press
ProductGroup: Book
Binding: Paperback

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ASIN: 0789004496

Customer Reviews:

4 out of 5 stars Useful for a newcomer to the clinical trial environment.......2001-05-04

As a clinical trials computer programmer, I'm not the primary target audience for this book. However, as an experienced programming consultant who was new to clinical studies in the pharmaceutical industry, I found it gave me a useful overview of the typical deliverables that my efforts supported. Acronyms that are frequently used in the clinical environment, such as IB (Investigator's Brochure) and ISS (Integrated Safety Study) are given some definition and examples are shown. I found this information valuable in enabling me to feel comfortable with these concepts when they were discussed in meetings with statisticians and project managers.

2 out of 5 stars Not a practical guide, more a manifesto !.......1998-04-18

Dr. Bonk is a seasoned professional who has worked at all levels of his craft, including the highest. This book is entitled "a practical guide for pharmaceutical research", and specifically concentrates on the output of documents from the pharmaceutical industry (regulatory documents and manuscripts, as well as, to a lesser extent, audio-visual preparations and computer-generated products). I bought the book because it was the only one that specifically addresses the needs of those of us working in the pharmaceutical industry.

This book is a manifesto, or one (alternative) philosophy, for the role of the medical writer in a pharmaceutical company. As such, its greatest achievement will be to attract people with talent into an occupation that is sorely in need of more and better writers. If this book stimulates under-graduates or graduates to explore this profession, then it will have made a significant, contribution to pharmaceutical research.

However, this book falls far short of being a practical guide. It is not, nor does it claim to be, a style guide; this is not a deficiency in itself. But to be a practical guide, there is much more that it needs to consider: how do medical writers multi-task, and manage their inevitably numerous assignments all at varying degrees of completion ? What should one look for in word processing software, and is this the same for everybody ? How can one enhance one's interactions with journal editors ? What are the relevant professional guilds and associations, and what are their courses and credentials like ? These are a few of the practical things, outside questions of style, that medical writers need to work inside the pharmaceutical industry.

The document templates provided (and lauded in the book's advertising) are poor. The regulatory documents should have followed closely the ICH or FDA guidelines (neither is new). A reprinted, stellar example of a published paper, with some illuminating commentary, and even some succes!sive stages of drafting, would have been an asset.

The initial sections of this book attempt to teach about the drug development process. Unless this can be done more thoroughly (and preferably by someone who has actually developed drugs), this description is inadequate to equip a medical writer in a pharmaceutical company. The descriptions are out of date and garbled in places. There are medical writers who indeed significantly contribute to drug development in the way that Dr. Bonk envisages, but they know a lot more than this about how new drugs are discovered and approved.

Lesser criticisms include the production of this book. At a little over 100 loosely worded pages it is not inexpensive. But its printing is cheap, and the figures were especially poorly printed in my copy. The figures, too, were often redundant; for example, the "pyramids" of the components of a medical journal manuscript were especially irrelevant.

In summary, this book is unique in giving a sound philosophy for the medical writer in a pharmaceutical company. As a practical guide (its stated claim) it is a real failure. This reviewer now understands why its plaudits were written by Professors of English in liberal arts schools, and not by experienced pharmaceutical industry personnel.

A.W.Fox, MD, PhD, FFPM

Proctor and Hughes' Chemical Hazards of the Workplace, 5th Edition
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    Proctor and Hughes' Chemical Hazards of the Workplace, 5th Edition
    Gloria J. Hathaway , and Nick H. Proctor
    Manufacturer: Wiley-Interscience
    ProductGroup: Book
    Binding: Hardcover

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    ASIN: 0471268836

    Book Description

    The indispensable resource for health professionals on potentially unsafe chemicals--now fully updated
    Proctor and Hughes' Chemical Hazards of the Workplace, Fifth Edition provides a comprehensive reference text for health professionals who need toxicology data on chemicals that may be encountered in various work settings. Building on the success of the Fourth Edition-already a standard text-this new edition updates and revises the more than 600 entries of that text, and also adds monographs on new compounds.
    Introductory chapters cover toxicological concepts, clinical manifestations of exposure, the diagnosis of occupational disease, and industrial hygiene aspects of chemical exposures. The rest of the text consists of more than 625 alphabetically arranged entries on individual compounds, each of which includes:
    * Chemical formula
    * CAS number
    * 2003 ACGIH (American Conference of Government Industrial Hygienists) threshold limit value
    * Synonyms
    * Physical properties
    * Sources of exposure
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    * Toxicological data
    The toxicological data includes both acute and chronic effects, especially as related to any known exposure levels. The data emphasizes human studies and cases over animal data whenever sufficient information is available, and addresses any known carcinogenic, mutagenic, fetotoxic, or other reproductive effects. Clinical information is presented in a succinct narrative form to aid in understanding.
    Easy to use, in-depth, and comprehensive, Proctor and Hughes' Chemical Hazards of the Workplace, Fifth Edition offers occupational health physicians, nurses, industrial hygienists, and other safety professionals an invaluable and up-to-date resource.
    Reproductive Hazards of the Workplace
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      Reproductive Hazards of the Workplace

      Manufacturer: Van Nostrand Reinhold
      ProductGroup: Book
      Binding: Hardcover

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      ASIN: 0442020422

      Book Description

      Reproductive Hazards of the Workplace Linda M. Frazier, MD, MPH Marvin L. Hage, MD In the face of rising medical costs, health care reform, intense media scrutiny, and the trend toward delayed pregnancies, the concern over on-the-job reproductive hazards is at an all-time high. The need to develop effective strategies for protecting the reproductive health of employees—female and male—is more critical than ever. Reproductive Hazards of the Workplace is designed to help managers, primary care physicians, and health and safety professionals manage and prevent occupational reproductive risks. Like other entries in Van Nostrand Reinhold's Hazards of the Workplace series, the book offers a wealth of valuable, up-to-date information plus expert-tested methodologies and advice for handling risk exposure. Reproductive Hazards of the Workplace begins by covering basic reproductive and developmental biology and fundamentals of risk assessment and reduction. It shows readers how to take into account influencing factors such as the employee's age, personal habits, and existing conditions (such as diabetes and hypertension). From this foundation, the text explains how to recognize and manage a wide range of potential threats to reproductive health, including: In describing reproductive risks involving these common occupational exposures, thorough coverage is provided of an often-ignored subject: reproductive hazards to men. Reproductive Hazards of the Workplace offers a variety of features to help readers use the material. Key tables, references, sample patient encounter forms, and occupational exposure guidelines add to the book's functionality. With this book, physicians, nurses, corporate personnel, and safety professionals have an expert resource focused exclusively on a crucial aspect of occupational health management. As an introductory text, a review volume, or a convenient sourcebook, Reproductive Hazards of the Workplace is a welcome addition to any safety professional's library.
      Proctor and Hughes' Chemical Hazards of the Workplace (Industrial Health & Safety)
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        Proctor and Hughes' Chemical Hazards of the Workplace (Industrial Health & Safety)
        Gloria J. Hathaway , Nick H. Proctor , and James P. MD Hughes
        Manufacturer: Van Nostrand Reinhold
        ProductGroup: Book
        Binding: Hardcover

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        ASIN: 0442020503

        Book Description

        Proctor & Hughes' Chemical Hazards of the Workplace Fourth Edition Gloria J. Hathaway • Nick H. Proctor • James P. Hughes For professionals in occupational health and related fields, one reference guide has earned a reputation as the indispensable resource on unsafe chemicals: Proctor and Hughes' Chemical Hazards of the Workplace. The legacy continues with this new edition; offering accurate, up-to-the-minute analyses of over 600 potentially dangerous chemicals all in a streamlined format that lets you find crucial information quickly and put it to work immediately. Since the previous edition of Proctor and Hughes' Chemical Hazards of the Workplace, more extensive research (including an increased number of human studies) has led to a better understanding of which chemicals are dangerous in a work environment and why. To reflect the latest advances and regulatory standards, this new edition incorporates: The proven Proctor and Hughes' format makes the following essential information supremely accessible: No occupational health professional should be without the new Fourth Edition of Proctor and Hughes' Chemical Hazards of the Workplace.
        List of MAK and BAT Values 1994: Maximum Concentrations and Biological Tolerance Values at the Workplace. Report No. 30 (MAK & BAT Values)
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          List of MAK and BAT Values 1994: Maximum Concentrations and Biological Tolerance Values at the Workplace. Report No. 30 (MAK & BAT Values)

          Manufacturer: Wiley-VCH
          ProductGroup: Book
          Binding: Hardcover

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          ASIN: 3527275649

          Book Description

          MAK values (Maximum Concentrations at the Workplace) and BAT values (Biological Tolerance Values) promote the protection of health at the workplace. They are used in occupational medicine for the risk- assessment of hazardous substances. The core of this report is a list of MAK values for more than 500 chemical compounds frequently detected at the workplace. Annotations are made for skin absorption, sensitization, pregnancy, genetic damage, peak limitation category, etc. Carcinogens are considered in detail seperately. The list is revised annually. 1994 in the focus of attention: respiratory allergens, MAK values and pregnancy and inorganic fibrous dust particles.

          The report is absolutely recommendable reading for toxicologists, chemists, industrial physicians and in a wider sense for all involved in the establishment of health and safety regulations.
          List of Mak and Bat Values 1996: Maximum Concentrations and Biological Tolerance Values at the Workplace (Report (Commission for the Investigation of Health Hazards of Chemical Compounds), 32)
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            List of Mak and Bat Values 1996: Maximum Concentrations and Biological Tolerance Values at the Workplace (Report (Commission for the Investigation of Health Hazards of Chemical Compounds), 32)
            Deutsche Forschungsgemeinschaft
            Manufacturer: Wiley-VCH Verlag GmbH
            ProductGroup: Book
            Binding: Paperback

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            ASIN: 352727572X

            Book Description

            MAK values (Maximum Concentrations at the Workplace) and BAT values (Biological Tolerance Values) promote the protection of health at the workplace. They are an efficient indicator for the toxic potential of chemical compounds. This book contains a list of scientifically recommended threshold limit values for more than 600 chemical compounds. Carcinogens, germ cell mutagens, embryotoxicants, sensitizing substances and those potentially bearing a risk to pregnancy are treated separately. The evaluations are revised annually by a commission of experts.

            The report is commendable reading for toxicologists, industrial physicians, chemists and for all involved in the establishment of health and safety regulations.
            List of MAK and BAT Values 1998: Maximum Concentrations and Biological Tolerance Values at the Workplace, Report No. 34
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              List of MAK and BAT Values 1998: Maximum Concentrations and Biological Tolerance Values at the Workplace, Report No. 34
              Edited by: Commission for the Investigation of Health of Chemical Compounds in the Work Area, Deutsche Forschungsgemeinschaft
              Manufacturer: John Wiley & Sons Inc
              ProductGroup: Book
              Binding: Paperback

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              ASIN: 3527275851
              Physical and Biological Hazards of the Workplace (Industrial Health & Safety)
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                Physical and Biological Hazards of the Workplace (Industrial Health & Safety)
                Peter H., M.D. Wald
                Manufacturer: Van Nostrand Reinhold Company
                ProductGroup: Book
                Binding: Paperback

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                ASIN: 0471285951

                Book Description

                This major reference on the health risks posed by physical and biological hazards in the workplace provides clear, detailed coverage of the many components of each hazard such as extremes of temperature and atmospheric pressure, energy hazards including noise, electricity, infared and ultraviolet light, lasers, magnetic fields, microwave and RF exposure, and ionizing radiation. Biological agents are covered in equal depth, plus viruses, bacteria, fungi, parasites, envenomations, and more.
                Physical Hazards of the Workplace (OCCUPATIONAL SAFETY AND HEALTH GUIDE SERIES)
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                  Physical Hazards of the Workplace (OCCUPATIONAL SAFETY AND HEALTH GUIDE SERIES)
                  Larry R. Collins , and Thomas D. Schneid
                  Manufacturer: CRC
                  ProductGroup: Book
                  Binding: Hardcover

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                  The recognition and control of hazards in the work environment is the cornerstone of every company's safety and health plan. There are dangers in every workplace, especially those devoted to technology, machinery, and potentially hazardous material. Employers and their management teams must understand the regulations that provide for facility safety. The successful implementation of these legal standards is required for the profitable and legitimate management of any business. Physical Hazards of the Workplace addresses environmental and occupational dangers on the factory floor and in the office. The author explores OSHA, DOT and other federal, state, and local regulatory compliance codes. He explains how to implement these regulations for the prevention and minimization of the growing number of hazards found in work environments. The author devotes individual chapters to dangers related to machines, the respiratory system, the circulatory system, confined spaces, chemicals, personnel, cumulative trauma, environmental issues, electricity, noise, fire and explosion, and the risk of falling. One key chapter discusses issues of emergency and disaster preparedness. The useful appendices concisely detail OSHA training requirements, posting standards, and more.

                  Safety, Health and Environmental Hazards at the Workplace
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                    Safety, Health and Environmental Hazards at the Workplace
                    A. J. P. Dalton
                    Manufacturer: Cassell
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                    Binding: Hardcover

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                    Working Safely in Health Care: A Practical Guide
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                      Working Safely in Health Care: A Practical Guide
                      Deborah Fell-Carlson
                      Manufacturer: Cengage Delmar Learning
                      ProductGroup: Book
                      Binding: Paperback

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                      Finally, a comprehensive resource on workplace safety designed with the health care worker in mind! This book will show you how to protect yourself and others from injury while on the job. You will be introduced to stresses and hazards unique to the health care environment, and provided with practical steps you can take to make work safer for you. If you know how to make work safer for yourself, you will be better equipped to provide a safe care environment for your clients.

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