Principles of Biomedical Sciences and IndustryImprove your product development skills to bring new ideas to biomedicineThe development of innovative healthcare products, such as biodegradable implants, biopharmaceuticals, or companion diagnostics, requires a multi-disciplinary approach that incorporates scientific evidence with novel and innovative ideas to create new and improved products and treatments. Indeed, product development and the...

This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation.A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration a...

In this fully revised and expanded fourth edition of the essential reference for clinical research coordinators, Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The books five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, and a glos...

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance.Covering t...

The third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensur...

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 pharmaceu...

Drug discovery increasingly requires a common understanding by researchers of the many and diverse factors that go into the making of new medicines. The scientist entering the field will immediately face important issues for which his education may not have prepared him: project teams, patent law, consultants, target product profiles, industry trends, Gantt charts, target validation, pharmacokinetics, proteomics, phenotype assays, biomarkers, and many other unfamiliar topics for which a ba...

The Future of Drug Discovery: Who decides which diseases to treat? provides a timely and detailed look at the efforts of the pharmaceutical industry and how they relate, or should relate, to societal needs. The authors posit that as a result of increasing risk aversion and accelerated savings in research and development, the industry is not developing drugs for increasingly prevalent diseases, such as Alzheimer's disease, untreatable pain, antibiotics and more. This book carefully exposes ...

"The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety...

A comprehensive guide to optimizing the lifecycle management of pharmaceutical brandsThe mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of brand drugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making t...

The supply and administration of medicines is an area of practice in which a number of healthcare professionals (e.g. nurses, pharmacists and allied health professionals) are involved. Prescribing is a relatively new role which many of these healthcare professionals have adopted. Medication Safety focuses on promoting safety in the delivery of medicines. Chapters explore the various stages in the medication process including safety in prescribing, dispensing and administering drugs. Advers...

Gain a complete understanding of the principles of quality improvement and their application to present and future pharmacy practice"This is a nice introduction to the concepts of continuous quality improvement. It is a comfortable read and is written at an elementary level in comparison to other textbooks in the pharmacy curriculum. This may be necessary, since the authors rightly conclude there is a lack of discussion of quality improvement in the pharmacy curric...