This text is aimed at potential clinical investigators usually physicians, especialy those thinking about doing clinical trials to evaluate new drugs - mostly sponsored by pharmaceutical companies.

Surgical education is a rapidly expanding area of surgical research and career interest, and as the Association for Academic Surgery (AAS) Fall Courses (www.aasurg.org) and International courses offer more and more specialty tracking there is a greater need for an accompanying textbook to supplement the material presented in the courses.

This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit. Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field. Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting.

Conceived and edited by Nigel Dent and Ramzan Visanji, Veterinary Clinical Trials form Concept to Completion is designed for both established practitioners and novices, offering alternative ways of conducting studies and ensuring that the studies are guided by Good Clinical Practices and are in compliance with regulations. Comprehensive in scope, it provides the scientific, biological, and regulatory background invaluable to teachers, researchers, and regulatory affairs staff, as well as those directly involved in clinical trials. The book covers: Objectives of the clinical study Control of the study Conduct of the study Regulation versus compliance Factors for success International harmonization activities Roles of the investigator, the monitor, and the practicing veterinarian Setting up GCP trials with particular animal species SOPs, the generic protocol, and the study report Contract research farms and multi-site studies Auditing With contributions from experts in every area of veterinary trials, the text has been organized with everyday use in mind. The chapters can be read sequentially for a comprehensive view or individually for coverage of particular topics and issues as needed. Drawing directly from the in-the-trenches experience of the editors and chapter authors, the book is a guide to methods that ensure studies meet regulatory compliance and strategies that ensure avoidance of common pitfalls.

The Textbook of Pharmaceutical Medicine is the standard reference for everyone working and learning in pharmaceutical medicine. It is a comprehensive resource covering the processes and practices by which medicines are developed, tested and approved, and the recognised text for the Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine. This fully revised Seventh Edition, which includes two new Editors, encompasses current developments within pharmaceutical medicine with new chapters on biological therapeutics, pharmacovigilance, vaccines, drugs for cancer, drug development in paediatrics and neonatalogy, the clinical trials directive, life cycle management of medicines, counterfeit medicines and medical marketing. Also included for easy reference, and referred to throughout the text, are the Declaration of Helsinki, Guidelines and Documentation for Implementation of Clinical Trials, relevant European Directives and the Syllabus for Pharmaceutical Medicine. Written by an international team of leading academics, medical directors and lawyers, The Textbook of Pharmaceutical Medicine, Seventh Edition meets the needs of both those working in pharmaceutical medicine and preparing for the Diploma in Pharmaceutical Medicine. The text breaks down into three core sections: Part I: Research and Development Part II: Regulation Part III: Healthcare marketplace View Table of Contents in detail

Written by and for Nurse Practitioners from a unique collaborative perspective, Primary Care: A Collaborative Practice, 4th Edition, prepares you to provide care for all of the major disorders of adults seen in the outpatient setting. Evidence-based content reflects the latest guidelines for primary care of hundreds of conditions, including hypertension, diabetes, and sexually transmitted infections. Now in full color, the 4th Edition includes chapters on emerging topics such as genetics, obesity, lifestyle management, and emergency preparedness. Combining a special blend of academic and clinical expertise, the author team provides a practical text/reference that promotes a truly collaborative primary care practice. Comprehensive, evidence-based content incorporates the latest standardized guidelines for primary care in today's fast-paced, collaborative environment. Unique! A collaborative perspective, reflecting the key roles of NPs, MDs, PAs, PharmDs, and others, promotes seamless continuity of care. A consistent format from chapter to chapters facilitates learning and clinical reference value. Diagnostics and Differential Diagnosis boxes provide a quick reference for diagnosing disorders and helping to develop effective management plans. Physician Consultation icons highlight situations or conditions in which consultation is either recommended or necessary. Emergency Referral icons identify signs and symptoms that indicate the need for immediate referral to an emergency facility. Co-management with Specialists discussions help you provide truly collaborative care in the outpatient setting. Complementary and alternative therapies are addressed where supported by solid research evidence.

Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.