Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
Download or read book The Fundamentals of Clinical Research written by P. Michael Dubinsky and published by John Wiley & Sons. This book was released on 2022-01-26 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
Download or read book Essentials of Clinical Research written by Stephen P. Glasser and published by Springer. This book was released on 2014-06-02 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.
Download or read book Fundamentals of Cancer Prevention written by David Alberts and published by Springer Science & Business Media. This book was released on 2008-09-24 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: An authoritative work that provides a detailed review of the current status of cancer prevention and control practice and research. This volume is an essential reference guide and tool for primary care physicians, the research community and students. Written as a collaborative work by the faculty of the nationally renowned Cancer Prevention and Control Program at the Arizona Cancer Center, this book brings together the expertise of specialists in the field of cancer prevention and control to provide the medical and research community that does not specialize in this field with insight to the disciplines of cancer prevention and control.
Download or read book Essentials of Clinical Trials written by Dr. Nilesh Panchal and published by DrMedHealth. This book was released on 2024-05-19 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essentials of Clinical Trials is an authoritative guide that offers a comprehensive exploration of the essential elements and advanced concepts in clinical research. This textbook delves into the fundamental principles of trial design, ethical considerations, data collection and management, and statistical methodologies, providing a clear and thorough understanding for students, researchers, and professionals. Additionally, it addresses contemporary topics such as adaptive trial designs, pragmatic trials, patient-reported outcomes, and precision medicine, highlighting the integration of big data and artificial intelligence. By combining practical insights with cutting-edge advancements, this book equips readers with the knowledge and tools needed to navigate the evolving landscape of clinical trials and contribute to the advancement of medical science.
Download or read book CLINICAL RESEARCH AND PHARMACOVIGILANCE written by Dr. Shivkumar Shete and published by JEC PUBLICATION. This book was released on with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical research and pharmacovigilance are fundamental domains in contemporary healthcare that propel therapeutic therapies forward and guarantee patient safety globally. We go through six important areas in this book, examining their importance, nuances, and the changing environment that influences them. The foundation of medical innovation is clinical research, which conducts extensive testing and refinement of novel medications, treatments, and medical technologies. This discipline aims to provide answers to important queries about the efficacy, safety, and effectiveness of healthcare therapies via well planned research. We explore the stages involved in clinical trials, moral issues, and the legal structure guiding these important studies. Another pillar of healthcare is pharmacovigilance, which is the continuous observation and assessment of pharmaceuticals after they have been approved. It aims to identify, evaluate, and lessen negative effects in order to maintain the advantage of therapies above their drawbacks. We examine the crucial procedures for risk assessment, signal detection, and adverse event reporting that support the security of medical devices.
Download or read book Fundamentals of Gcp and Clinical Research written by MR Sanjay Gupta and published by Cr Books Pvt. Limited. This book was released on 2013-08-15 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book is intended to provide a fundamental knowledge on clinical research and Good Clinical Practice (GCP) guidelines. I hope the book will leave the desired impression and readers would be able to incorporate the learning into practice." (From the preface)
Download or read book Essentials for Quality and Safety Improvement in Health Care written by Christopher Ente and published by Springer Nature. This book was released on 2022-02-01 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patient safety and quality improvement in health care remain a global priority. Subpar performance in health care, however, is still common more than a decade after the christening of patient safety in Africa. The core principle of safety and quality improvement systems is to identify and assess the root cause of failures in order to learn from them and devise a means to improve and to avoid recurrence. This book is designed to encourage, facilitate and empower healthcare workers in the development and implementation of strategically driven patient safety and quality improvement initiatives for safer healthcare systems and healthcare facilities in low- and middle-income countries (LMICs) of Africa. It also highlights some of the profound challenges and barriers to designing and implementing patient safety and quality improvement interventions or programmes in the region and reiterates the need to remain focused and determined to work out solutions with confidence and overcome these barriers. In the book, chapters highlight six essential components crucial for achieving evolutionary progress in safety and quality improvement in a healthcare system: Standard operating procedure Audit Research Safety management Quality management Evaluation Practical steps in planning and conducting these six essential components are outlined with some specific features to aid learning and facilitate their implementation. The authors have experience and expertise in the medical practice gained in Africa and a decade of knowledge and experience from consultancy work in safety and quality improvement in health care within and outside the region. Essentials for Quality and Safety Improvement in Health Care: A Resource for Developing Countries is authored for both medical professionals and those from other professions who are interested in and enthusiastic about patient safety and healthcare quality and therefore willing to build a career in this field. It is relevant to all health institutions, health and non-health workers, and can be used as a checklist while rendering quality and safe health care.
Download or read book Pharmacovigilance Essentials written by Mukesh Nandave and published by Springer Nature. This book was released on with total page 478 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Essentials of Translational Pediatric Drug Development written by Elke Gasthuys and published by Elsevier. This book was released on 2024-07-23 with total page 732 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essentials of Translational Pediatric Drug Development: From Past Needs to Future Opportunities provides integrated and up-to-date insights relevant for both translational researchers and clinicians active in the field of pediatric drug development. The book covers all key aspects from different stakeholder perspectives, providing a literature overview and careful reflection on state-of-the-art approaches. It will be an ideal guide for researchers in the field who are designing and performing high quality, innovative pediatric-adapted drug development by helping them define needs/challenges and possible solutions that advance and harmonize pediatric drug development.Despite the broad consensus that children merit the same quality of drug treatment as any other age group, children remain frequently neglected during drug research and development. Even with the adoption of multiple legislations addressing this problem, the lack of efficacy and safety data of marketed as well as newly developed drugs still remain in the pediatric population. - Covers both theoretical and practical aspects of translational pediatric drug development - Approaches the topic from different stakeholder perspectives (academics, industry, regulators, clinicians and patient/parent advocacy groups) - Offers best practices and future perspectives for the improvement of translational pediatric drug development
Download or read book Essentials of Physician Practice Management written by Blair A. Keagy and published by John Wiley & Sons. This book was released on 2012-06-14 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essentials of Physician Practice Management offers a practical reference for administrators and medical directors and provides a comprehensive text for those preparing for a career in medical administration, practice management, and health plan administration. Essentials of Physician Practice Management is filled with valuable insights into every aspect of medical practice management including operations, financial management, strategic planning, regulation and risk management, human resources, and community relations.
Download or read book ESSENTIALS OF BIOSTATISTICS AND RESEARCH METHODOLOGY written by INDRANIL SAHA and published by Academic Publishers. This book was released on 2023-04-14 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: THIS TEXTBOOK IS A COMPREHENSIVE USER FRIENDLY AND EASY TO READ RESOURCE ON BIOSTATISTICS AND RESEARCH METHODOLOGY. IT IS MEANT FOR UNDERGRADUATE AND POSTGRADUATE MEDICAL STUDENTS AND ALLIED BIOMEDICAL SCIENCES. HEALTH RESEARCHERS, RESEARCH SUPERVISORS AND FACULTY MEMBERS MAY FIND IT USEFUL AS A REFERENCE BOOK
Download or read book Essentials of Epidemiology in Public Health written by Ann Aschengrau and published by Jones & Bartlett Learning. This book was released on 2013-06-03 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: 5733-8
Download or read book Introduction to Basics of Pharmacology and Toxicology written by Mageshwaran Lakshmanan and published by Springer Nature. This book was released on 2022-11-15 with total page 900 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume is designed to impart the fundamental concepts in experimental pharmacology, research methodology and biostatistics. Through this book, the readers will learn about different methods involved in drug discovery, experimental animals and their care, equipments and the various bioassays used in experimental pharmacology. This book contains special sections on various drug screening methods involved in the evaluation of different body systems. Certain sections provide the healthcare professionals with the knowledge necessary to interpret clinical research articles, design clinical studies, and learn essential concepts in biostatistics in an expedient and concise manner. Basic principles and applications of simple analytical methods employed in drug analysis are well written under one section. It focuses on the basic and advanced laboratory techniques and also on computer simulated data, written extensively under the Biostatistics section. The methods used for drug analysis have been described in adequate detail with cross-references for further studies and comprehension. Overall, the book is designed systematically with four broad sections with extensive subdivisions for easy tracking, interpretation, and understanding.
Download or read book Research Methods in Psychiatry written by Chris Freeman and published by RCPsych Publications. This book was released on 2006-12 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updated comprehensive guide to psychiatric research methods takes the reader from getting started in research through to publishing a paper, with advice on avoiding common pitfalls along the way. Systematic analysis and meta-analysis, epidemiology, qualitative research, and research focused on a few patients are discussed, together with the principles of validity and reliability in the assessment of psychological variables and statistical aspects of the design and analysis of clinical trials. Five completely new chapters cover topics such as research from the trainee's perspective and research in learning disability and child and adolescent psychiatry. A key text for psychiatric trainees embarking on research projects, this book will also be useful to psychiatrists supervising research projects, and those in the social sciences with an interest in carrying out research or critically reviewing the published evidence. Topics covered include setting up a research project, how to make a comprehensive review of the literature, choosing a rating scale, and getting research published.
Download or read book Clinical Trials Audit Preparation written by Vera Mihajlovic-Madzarevic and published by John Wiley & Sons. This book was released on 2010-09-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development
Download or read book Using the Pharmaceutical Literature written by Sharon Srodin and published by CRC Press. This book was released on 2006-02-16 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: Gathering information of critical importance for professionals in the pharmaceutical and medical device industries, this guide provides a comprehensive overview of key resources, such as databases, on-line directories, reports, and periodicals-providing at-a-glance guidance and collection development tools for information professionals in this fiel
