Medical Writing In Drug Development

Author : Robert J Bonk
Publisher : Routledge
Page : 193 pages
File Size : 41,8 Mb
Release : 2014-01-02
Category : Business & Economics
ISBN : 9781317971412

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Medical Writing in Drug Development by Robert J Bonk Pdf

A guide through the maze of the pharmaceutical research and development process, Medical Writing in Drug Development fills a gap in the libraries of technical writers, college instructors, and corporate professionals associated with the pharmaceutical process. As it discusses critical information, such as strategies and techniques pivotal to crafting documents for drug development, it also overviews drug research, document types, the roles of professional writers, and information technology. In no time at all, you will be creating persuasive technical documents, building complex facts into coherent messages, and contributing to the effective marketing of new products with promotional pieces that meet legal and ethical standards. Medical Writing in Drug Development helps medical writers and scientific, regulatory, and marketing professionals develop a working knowledge of the technical documents crucial to successful drug research. New and seasoned professional writers alike will benefit from the book's detailed discussions of: using abstracts, slides, and posters to present up-to-the-minute research how patient-education materials, health-economic assessments, and electronic journals provide ongoing challenges in medical writing a dossier approach that expedites regulatory submissions for international drug development structural constraints and rhetorical approaches toward regulatory documents presenting intricate information in scientifically unbiased, yet technically convincing language the effects of electronic publishing, computer graphics, and related technology on the practice of medical writing within pharmaceutical research Practical as a foundation text for undergraduate, graduate, and certificate programs in pharmaceutical or medical technical writing, Medical Writing in Drug Development will help you develop practical strategies for handling journal manuscripts, conference materials, and promotional pieces. No other text will clarify the main aspects of the pharmaceutical research and development process while offering you insight on the key issues dominating the healthcare arena.

Author : Pieter H. Joubert,Silvia M. Rogers
Publisher : Springer
Page : 140 pages
File Size : 46,9 Mb
Release : 2015-11-27
Category : Medical
ISBN : 9783662483169

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Strategic Scientific and Medical Writing by Pieter H. Joubert,Silvia M. Rogers Pdf

A document may be based on accurate medical and scientific information, follow guidelines precisely, and be well written in clear and correct language, but may still fail to achieve its objectives. The strategic approach described in this book will help you to turn good medical and scientific writing into successful writing. It describes clearly and concisely how to identify the target audience and the desired outcome, and how to construct key messages for a wide spectrum of documents. Irrespective of your level of expertise and your seniority in the pharmaceutical, regulatory, or academic environment, this book is an essential addition to your supporting library. The authors share with you many years of combined experience in the pharmaceutical and academic environment and in the writing of successful outcome-driven documents.​

Author : Justina Orleans-Lindsay
Publisher : John Wiley & Sons
Page : 182 pages
File Size : 51,7 Mb
Release : 2012-06-22
Category : Medical
ISBN : 9781118302064

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Pharmacovigilance Medical Writing by Justina Orleans-Lindsay Pdf

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.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.

Author : Linda Fossati Wood,MaryAnn Foote
Publisher : Springer Science & Business Media
Page : 238 pages
File Size : 50,5 Mb
Release : 2009-01-05
Category : Medical
ISBN : 9783764383626

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Targeted Regulatory Writing Techniques: Clinical Documents for Drugs and Biologics by Linda Fossati Wood,MaryAnn Foote Pdf

This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.

Author : Jocelyn Jennings,Linda McBride
Publisher : Unknown
Page : 128 pages
File Size : 45,8 Mb
Release : 2021-11-26
Category : Electronic
ISBN : 1947493736

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Global Pediatric Development of Drugs, Biologics, and Medical Devices by Jocelyn Jennings,Linda McBride Pdf

Author : Viswanatha Mathad,D. Anusuya
Publisher : Bsp Books Pvt. Limited
Page : 214 pages
File Size : 44,8 Mb
Release : 2016-10-07
Category : Medical
ISBN : 9352301048

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Medicomarketing Writing by Viswanatha Mathad,D. Anusuya Pdf

Medical writing is part of drug development process. Medicomarketing writing is a type of medical writing where scientific information is presented as promotional literatures. Medicomarketing communication or healthcare communication has evolved as a profession over a decade. More and more pharmaceutical industries are outsourcing their work to medicomarketing communication or healthcare communication companies and freelance medical writers. The skills required for medicomarketing writing are different from the skills required for any other profession. With more than 15 years of experience in medicomarketing communication segment, we have identified the skills required for medicomarketing writing and the lack of skill among the pharmacists, doctors and life science graduates, who have the ability to excel in medical writing. This is the first book, which gives practical insights into medicomarketing writing. This book is ideal for graduates and postgraduates in -Pharmacy -Medicine -Dentistry and -Life science This book is also useful for -Newbie medicomarketing writers -Product managers and medical advisors working in pharmaceutical companies -Senior medical writers working in publishing companies -Team leaders and project managers working in medical communication and medical advertising agencies -Freelance medical writers

Author : Toby Freedman
Publisher : CSHL Press
Page : 408 pages
File Size : 55,7 Mb
Release : 2008
Category : Biotechnology
ISBN : 9780879697259

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Career Opportunities in Biotechnology and Drug Development by Toby Freedman Pdf

An essential guide for students in the life sciences, established researchers, and career counselors, this resource features discussions of job security, future trends, and potential career paths. Even those already working in the industry will find helpful information on how to take advantage of opportunities within their own companies and elsewhere.

Author : Samiran Nundy,Atul Kakar,Zulfiqar A. Bhutta
Publisher : Springer Nature
Page : 475 pages
File Size : 50,7 Mb
Release : 2021-10-23
Category : Medical
ISBN : 9789811652486

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How to Practice Academic Medicine and Publish from Developing Countries? by Samiran Nundy,Atul Kakar,Zulfiqar A. Bhutta Pdf

This is an open access book. The book provides an overview of the state of research in developing countries – Africa, Latin America, and Asia (especially India) and why research and publications are important in these regions. It addresses budding but struggling academics in low and middle-income countries. It is written mainly by senior colleagues who have experienced and recognized the challenges with design, documentation, and publication of health research in the developing world. The book includes short chapters providing insight into planning research at the undergraduate or postgraduate level, issues related to research ethics, and conduct of clinical trials. It also serves as a guide towards establishing a research question and research methodology. It covers important concepts such as writing a paper, the submission process, dealing with rejection and revisions, and covers additional topics such as planning lectures and presentations. The book will be useful for graduates, postgraduates, teachers as well as physicians and practitioners all over the developing world who are interested in academic medicine and wish to do medical research.

Author : Amir Kalali,Sheldon Preskorn,Joseph Kwentus
Publisher : Cambridge University Press
Page : 219 pages
File Size : 52,9 Mb
Release : 2012-06-07
Category : Medical
ISBN : 9780521766067

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Essential CNS Drug Development by Amir Kalali,Sheldon Preskorn,Joseph Kwentus Pdf

Presents the complicated process of CNS drug development in a way that is engaging and informative for professionals and students.

Author : Divya Vohora,Gursharan Singh
Publisher : Academic Press
Page : 526 pages
File Size : 48,6 Mb
Release : 2017-11-14
Category : Medical
ISBN : 9780128020982

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Pharmaceutical Medicine and Translational Clinical Research by Divya Vohora,Gursharan Singh Pdf

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

Author : Brian G. Bass,Cynthia L. Kryder CCC-Sp
Publisher : Accidental Medical Writer
Page : 137 pages
File Size : 48,8 Mb
Release : 2008
Category : Business & Economics
ISBN : 9781601455840

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The Accidental Medical Writer by Brian G. Bass,Cynthia L. Kryder CCC-Sp Pdf

The authors share the benefits of their almost 40 years of experience in establishing careers as freelance medical writers, providing tips for anyone interested in the profession.

Author : Mitchell N. Cayen
Publisher : John Wiley & Sons
Page : 507 pages
File Size : 45,9 Mb
Release : 2011-02-25
Category : Medical
ISBN : 9781118035207

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Early Drug Development by Mitchell N. Cayen Pdf

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 interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.

Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 48,5 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309042864

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Modern Methods of Clinical Investigation by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf

The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Author : Stephen S. Senn
Publisher : John Wiley & Sons
Page : 523 pages
File Size : 46,9 Mb
Release : 2008-02-28
Category : Medical
ISBN : 0470723572

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Statistical Issues in Drug Development by Stephen S. Senn Pdf

Drug development is the process of finding and producingtherapeutically useful pharmaceuticals, turning them into safe andeffective medicine, and producing reliable information regardingthe appropriate dosage and dosing intervals. With regulatoryauthorities demanding increasingly higher standards in suchdevelopments, statistics has become an intrinsic and criticalelement in the design and conduct of drug development programmes. Statistical Issues in Drug Development presents anessential and thought provoking guide to the statistical issues andcontroversies involved in drug development. This highly readable second edition has been updated toinclude: Comprehensive coverage of the design and interpretation ofclinical trials. Expanded sections on missing data, equivalence, meta-analysisand dose finding. An examination of both Bayesian and frequentist methods. A new chapter on pharmacogenomics and expanded coverage ofpharmaco-epidemiology and pharmaco-economics. Coverage of the ICH guidelines, in particular ICH E9,Statistical Principles for Clinical Trials. It is hoped that the book will stimulate dialogue betweenstatisticians and life scientists working within the pharmaceuticalindustry. The accessible and wide-ranging coverage make itessential reading for both statisticians and non-statisticiansworking in the pharmaceutical industry, regulatory bodies andmedical research institutes. There is also much to benefitundergraduate and postgraduate students whose courses include amedical statistics component.

Author : Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
Publisher : John Wiley & Sons
Page : 782 pages
File Size : 53,5 Mb
Release : 2013-05-20
Category : Medical
ISBN : 9781118312056

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Pediatric Drug Development by Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis Pdf

Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.