Группа авторов
Список книг автора Группа авторовThe Management of Chemical Process Development in the Pharmaceutical Industry
Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work. This book illustrates practical considerations through many examples of the successful direction and integration of the activities of chemists, analysts, chemical engineers, and biologists, as well as safety, regulatory, and environmental professionals in productive teams. Moreover, this reference provides guidance on: Directing and carrying out specific tasks and courses of action Making and communicating clear and achievable decisions Solving problems on the spot Managing the administrative aspects of chemical process development The author, Dr. Derek Walker, has directed chemical process development work for four decades, combining firsthand chemical synthesis experience with many other disciplines needed to create chemical processes. You will benefit from his advice and unique insights into: Understanding the workings of matrix organizations Defining missions and creating action plans Developing interdisciplinary approaches to problem solving Holding review meetings, revising goals, and motivating staff Prioritizing programs and responses to emergencies In addition, you'll learn how successful chemists, in collaboration with other disciplines, define the best (green) chemistry for process scale-up, including accommodating FDA requirements in the last process steps and addressing safety and environmental matters early in their work. Case studies provide incisive perspective on these issues. A chapter on recognizing and patenting intellectual property emphasizes the importance of comprehensive literature surveys and understanding invention. A chapter on the future challenges you to think beyond narrow constraints and explore new horizons.
Development and Approval of Combination Products
A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufacturing stages. Written from an FDA regulatory perspective, the book not only enables you to bring a successful combination drug product to market, it also sets forth the most efficient and effective path to FDA approval. The book begins with an introductory chapter presenting definitions and basic regulatory principles of combination products. Next, it reviews manufacturing and controls, preclinical testing models, pharmacology, clinical testing, regulatory submissions, FDA reviews, and approvals. Among the key topics examined are: * The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products * Approaches to clinical trial protocol design and execution * Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products * Key sponsor/FDA meetings and negotiations essential for approval and commercialization Case studies involving such actual combination products as Mylotarg, Herceptin, and HercepTest help you better understand how to implement the author's practical guidelines. References at the end of each chapter enable you to find more information on any stage of the development, manufacturing and approval processes. This book is ideal for researchers, regulators, academics, project managers, and executives involved in the complex process of combination product development. Not only does itoffer a comprehensive guide to the technical aspects of the field, it also integrates all ofthese technical aspects into a unified, effective approach to help ensure a successful, approved product.
Essential Statistics for the Pharmaceutical Sciences
… this text takes a novel approach… The style… is not as dry as other statistics texts, and so should not be intimidating even to a relative newcomer to the subject… The layout is easy to navigate, there are chapter aims, summaries and “key point boxes” throughout. -The Pharmaceutical Journal, 2008 This text is a clear, accessible introduction to the key statistical techniques employed for the analysis of data within this subject area. Written in a concise and logical manner, the book explains why statistics are necessary and discusses the issues that experimentalists need to consider. The reader is carefully taken through the whole process, from planning an experiment to interpreting the results, avoiding unnecessary calculation methodology. The most commonly used statistical methods are described in terms of their purpose, when they should be used and what they mean once they have been performed. Numerous examples are provided throughout the text, all within a pharmaceutical context, with key points highlighted in summary boxes to aid student understanding. Essential Statistics for the Pharmaceutical Sciences takes a new and innovative approach to statistics with an informal style that will appeal to the reader who finds statistics a challenge! This book is an invaluable introduction to statistics for any science student. It is an essential text for students taking biomedical or pharmaceutical-based science degrees and also a useful guide for researchers.
Manual for Eye Examination and Diagnosis
Health professionals and students need look no further than the seventh edition of Leitman's Manual for Eye Examination and Diagnosis for a concise introduction to eye diagnosis and treatment. Designed to be read cover-to-cover, this short, well illustrated text summarizes key points needed for understanding basic examination techniques, use of instruments and major ophthalmic disorders. It provides a strong foundation of knowledge on which to grow and enjoy this ever-changing speciality. Manual for Eye Examination and Diagnosis is the only complete overview of eyecare available in such an easy-to-read format, and features: Over 360 full-color illustrations and clinical photographs Coverage of the fundamentals with practical, clinical points Updated information on refractive surgery, glaucoma surgery and neuro-ophthalmology Latest information on tests such as OCT and optic nerve fiber scanning.
101 Healing Stories for Kids and Teens
A comprehensive guide to understanding and using storytelling in therapy with kids and teens «George Burns is a highly experienced clinician with the remarkable ability to create, discover, and tell engaging stories that can teach us all the most important lessons in life. With 101 Healing Stories for Kids and Teens, he strives especially to help kids and teens learn these life lessons early on, providing them opportunities for getting help and even learning to think preventively.» -Michael D. Yapko, PhD | Author of Breaking the Patterns of Depression and Hand-Me-Down Blues «George Burns takes the reader on a wonderful journey, balancing metaphor, good therapeutic technique, and empirical foundations during the trip. Given that Burns utilizes all three aspects of the Confucian story referred to in the book-teaching, showing, and involving-readers should increase their understanding of how stories can be used therapeutically.» -Richard G. Whiteside, MSW | Author of The Art of Using and Losing Control and Working with Difficult Clients: A Practical Guide to Better Therapy «A treasure trove for parents and for professionals in the child-development fields.» -Jeffrey K. Zeig, PhD | Director, The Milton H. Erickson Foundation Stories can play an important and potent role in therapy with children and adolescents-helping them develop the skills to cope with and survive a myriad of life situations. In many cases, stories provide the most effective means of communicating what kids and teens might not want to discuss directly. 101 Healing Stories for Kids and Teens provides straightforward advice on using storytelling and metaphors in a variety of therapeutic settings. Ideal for all who work with young people, this unique resource can be combined with other inventive and evidence-based techniques such as play, art, music, and drama therapies as well as solution focused, hypnotic, and cognitive-behavioral approaches. Offering guidance for new clinicians and seasoned professionals, George Burns's latest work delivers a unique combination-information on incorporating storytelling in therapy, dozens of ready-made stories, and tips for creating original therapeutic stories. Innovative chapters include: * Guidance for effective storytelling * Using metaphors effectively * Where to get ideas for healing stories * Planning and presenting healing stories * Teaching parents to use healing stories In addition, 101 Healing Stories for Kids and Teens includes dozens of story ideas designed to address a variety of issues, such as: * Enriching learning * Teaching self-care * Changing patterns of behavior * Managing relationships, emotions, and life challenges * Creating helpful thoughts * Developing life skills and problem-solving techniques
Reflective Interpersonal Therapy for Children and Parents
Disruptive and aggressive behaviour in children causes significant distress to everyone involved. Tradition interventions tend to focus on changing the disruptive behaviour itself, but research shows that it is important to also focus on the underlying anxiety, anger and vulnerability that may have contributed to the child’s conduct. In this innovative book, Hermione Roff introduces Reflective Interpersonal Therapy for Children and Parents (RICAP), a new intervention that looks at the processes underpinning disruptive and aggressive behaviour problems. RICAP was developed specifically to meet the needs of children and their families, and offers a new way to think about and tackle conduct disorders. The intervention explores the relationship between anxiety and anger, the dynamics of threat and fear, and the behavioural interactions within a prime relationship. Taking a practitioner-oriented approach, Roff introduces the theory underpinning RICAP, the evidence base for the approach and how it can be put to work in clinical practice.
Person-Based Cognitive Therapy for Distressing Psychosis
This book provides a practical framework for using a person based cognitive therapy approach for addressing the range of problems experienced by people with psychosis. Chapters 1-4 provide a context for the approach and chapters 5-12 cover the clinical application of the approach. Key features include; the integration of the author’s work on Mindfulness (simple meditation technique that is similarly creating a lot of interest at present) for people with psychosis; inclusion of the two-chair method; plus a chapter on group therapy.
What's Wrong with the Europe Union and How to Fix It
The European Union seems incapable of undertaking economic reforms and defining its place in the world. Public apathy towards the EU is also increasing, as citizens feel isolated from the institutions in Brussels and see no way to influence European level decisions. Taking a diagnosis and cure approach to the EU’s difficulties, Simon Hix tackles these problems with distinct clarity and open-mindedness. What the EU needs, Hix contends, is more open political competition. This would promote policy innovation, foster coalitions across the institutions, provide incentives for the media to cover developments in Brussels, and enable citizens to identify who governs in the EU and to take sides in policy debates. The EU is ready for this new challenge. The institutional reforms since the 1980s have transformed the EU into a more competitive polity, and political battles and coalitions are developing inside and between the European Parliament, the Council, and the Commission. This emerging politics should be more central to the Brussels policy process, with clearer coalitions and identifiable winners and losers, at least in the short term. The risks are low because the EU has multiple checks-and-balances. Yet, the potential benefits are high, as more open politics could enable the EU to overcome policy gridlock, rebuild public support, and reduce the democratic deficit. This indispensable book will be of great interest to students of the European politics, scholars, policy makers and anyone concerned with the future of the European Union.
10 Good Questions About Life And Death
10 Good Questions about Life and Death makes us think again about some of the most important issues we ever have to face. Addresses the fundamental questions that many of us ask about life and death. Written in an engaging and straightforward style, ideal for those with no formal background in philosophy. Focuses on commonly pondered issues, such as: Is life sacred? Is it bad to die? Is there life after death? Does life have meaning? And which life is best? Encourages readers to think about and respond to the human condition. Features case studies, thought-experiments, and references to literature, film, music, religion and myth.
The Practical Guide to the Genetic Family History
The Practical Guide to The Genetic Family History Robin L. Bennett Compiling the most recent genetic developments in medical specialties, The Practical Guide to the Genetic Family History is a valuable resource which outlines the proper methods for taking and recording a patient's family medical history, allowing primary care physicians to be more efficient in diagnosing conditions with potential genetic components. With genetic screening forms, an overview of directed questions, pedigree nomenclature, and outlining common approaches used, genetic counselor Robin L. Bennett provides readers with the basic foundation in human genetics necessary to recognize inherited disorders and familial disease susceptibility in patients. As the only guide which is geared for the physician in this field, The Practical Guide to the Genetic Family History includes remarks by renowned medical geneticist Arno Motulsky, as well as information on structuring an accurate pedigree and its components, including: * Using a pedigree to identify individuals with an increased susceptibility to cancer * Family history, adoption, and their challenges * The connection between the pedigree and assisted reproductive technologies * Making referrals for genetic services * Neurological and neuromuscular conditions * Tables covering hearing loss, mental retardation, dementia, and seizures * Five case studies of genetics in practice An essential reference for genetics clinics, medical geneticists, and counselors, The Practical Guide to the Genetic Family History is also an invaluable aid for both primary care and specialist physicians who need an up-to-date reference that emphasizes both the science and art of modern clinical genetics.