Pharmaceutical researchers are constantly looking for drug products, drug delivery systems and devices for improving the health of society. A scientific and systematic search for new knowledge requires a thorough understanding of research methods and hypothesis design. This volume presents pharmaceutical research through theoretical concepts, methodologies and ethical issues. It fulfils publication ethics course work requirements for students. Chapters have been designed to cater for the curriculum requirements of universities globally. This serves as a guide on how to apply concepts in designing experiments and transforming laboratory research into actual practice. Features: · Complete coverage of research methodology courses for graduate and postgraduate students globally. · Step-by-step assistance in writing technical reports, projects, protocols, theses and dissertations. · Experimental designing in pharmaceutical formulation development and preclinical research designs. · Ethics in using animals in preclinical research and humans in clinical research. · Publication ethics, best practices and guidelines for ensuring ethical writing. · Hypothetical and real-world case studies on ethical issues and measures for prevention and control.

Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the unique concerns that arise in specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that occur when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging questions in human subjects research, namely financial conflicts of interest and the interpretation of scientific data.

Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.

This book is designed to introduce doctoral and graduate students to the process of conducting scientific research in the social sciences, business, education, public health, and related disciplines. It is a one-stop, comprehensive, and compact source for foundational concepts in behavioral research, and can serve as a stand-alone text or as a supplement to research readings in any doctoral seminar or research methods class. This book is currently used as a research text at universities on six continents and will shortly be available in nine different languages.

100 Questions (and Answers) About Research Ethics by Emily E Anderson and Amy Corneli is an essential guide for graduate students and researchers in the social and behavioral sciences. It identifies ethical issues that individuals must consider when planning research studies as well as provides guidance on how to address ethical issues that might arise during research implementation. Questions such as assessing risks, to protecting privacy and vulnerable populations, obtaining informed consent, using technology including social media, negotiating the IRB process, and handling data ethically are covered. Acting as a resource for students developing their thesis and dissertation proposals and for junior faculty designing research, this book reflects the latest U.S. federal research regulations to take effect mostly in January 2018.

Emerging methods, as well as best practices in well-used methods, in pharmacy are of great benefit to researchers, graduate students, graduate programs, residents and fellows also in other health science areas. Researchers require a text to assist in the design of experiments to address seemingly age-old problems. New interventions are needed to improve medication adherence, patients' lived experiences in health care, provider-patient relationships, and even various facets of pharmacogenomics. Advances in systems re-engineering can optimize health care practitioners' roles. Contemporary Research Methods in Pharmacy and Health Services includes multi-authored chapters by renowned experts in their field. Chapters cover examples in pharmacy, health services and others transcendent of medical care, following a standardized format, including key research points; valid and invalid assumptions; pitfalls to avoid; applications; and further inquiry. This is a valuable resource for researchers both in academia and corporate R&D, primarily in pharmacy but also in health services, and other health disciplines. Social science researchers and government scientists can also benefit from the reading. - Provides multi-authored chapters by renowned experts in their field - Includes examples for pharmacy and health services and others that are transcendent of medical care - Covers key research points, valid and invalid assumptions, pitfalls to avoid, applications, and further inquiry

Principles of Research Design and Drug Literature Evaluation is a unique resource that provides a balanced approach covering critical elements of clinical research, biostatistical principles, and scientific literature evaluation techniques for evidence-based medicine. This accessible text provides comprehensive course content that meets and exceeds the curriculum standards set by the Accreditation Council for Pharmacy Education (ACPE). Written by expert authors specializing in pharmacy practice and research, this valuable text will provide pharmacy students and practitioners with a thorough understanding of the principles and practices of drug literature evaluation with a strong grounding in research and biostatistical principles. Principles of Research Design and Drug Literature Evaluation is an ideal foundation for professional pharmacy students and a key resource for pharmacy residents, research fellows, practitioners, and clinical researchers. FEATURES * Chapter Pedagogy: Learning Objectives, Review Questions, References, and Online Resources * Instructor Resources: PowerPoint Presentations, Test Bank, and an Answer Key * Student Resources: a Navigate Companion Website, including Crossword Puzzles, Interactive Flash Cards, Interactive Glossary, Matching Questions, and Web Links From the Foreword: "This book was designed to provide and encourage practitioner’s development and use of critical drug information evaluation skills through a deeper understanding of the foundational principles of study design and statistical methods. Because guidance on how a study’s limited findings should not be used is rare, practitioners must understand and evaluate for themselves the veracity and implications of the inherently limited primary literature findings they use as sources of drug information to make evidence-based decisions together with their patients. The editors organized the book into three supporting sections to meet their pedagogical goals and address practitioners’ needs in translating research into practice. Thanks to the editors, authors, and content of this book, you can now be more prepared than ever before for translating research into practice." L. Douglas Ried, PhD, FAPhA Editor-in-Chief Emeritus, Journal of the American Pharmacists Association Professor and Associate Dean for Academic Affairs, College of Pharmacy, University of Texas at Tyler, Tyler, Texas

Scientific research ethics vary by discipline and by country, and this analysis sought to understand those variations. The authors reviewed literature and conducted interviews to provide researchers, government officials, and others who create, modify, and enforce ethics in scientific research around the world with an understanding of how ethics are created, monitored, and enforced across scientific disciplines and across international borders.

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Pharmacists face ethical choices constantly -- sometimes dramatic life-and-death decisions, but more often subtle, less conspicuous choices that are nonetheless important. Among the topics confronted are assisted suicide, conscientious refusal, pain management, equitable distribution of drug resources within institutions and managed care plans, confidentiality, and alternative and non-traditional therapies. Veatch and Haddad's book, first published in 1999, was the first collection of case studies based on the real experiences of practicing pharmacists, for use as a teaching tool for pharmacy students. The second edition accounts for the many changes in pharmacy since 1999, including assisted suicide in Oregon, the purchasing of less expensive drugs from Canada, and the influence of managed care on prescriptions. The presentation of some cases is shortened, most are revised and updated, and two new chapters have been added. The first new chapter presents a new model for analyzing cases, while the second focuses on the ethics of new drug distribution systems, for example hospitals where pharmacists are forced to choose drugs based on cost-effectiveness, and internet based pharmacies.