Наличие на складе: Есть (1 шт.) Описание: This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector - whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab.
Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.
Автор: Matthews, Janice R. (Scientific Editing Services) Matthews, Robert W. (University of Georgia) Название: Successful Scientific Writing.A Step-by-Step Guide for the Biological and Medical Sciences ISBN: 1107691931 ISBN-13(EAN): 9781107691933 Издательство: Cambridge Academ Рейтинг: Цена: 5544.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The new edition of this best-selling guide has been thoroughly updated for today`s digital world, covering all aspects of the writing process and now including extensive coverage of ethical issues, including plagiarism. It offers a rich blend of practical advice, abundant examples from actual manuscripts, and hands-on exercises.
Автор: Ward Kevin R., Matejtschuk Paul Название: Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches ISBN: 1493989278 ISBN-13(EAN): 9781493989270 Издательство: Springer Рейтинг: Цена: 16630.00 р. 23757.00-30% Наличие на складе: Есть (1 шт.) Описание: This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector - whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab.
Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.
Explores the social inequality of clinical drug testing and its effects on scientific results
Imagine that you are testing the safety and efficacy of an experimental drug in what is called a Phase I trial. The only direct benefit to you of participating is that you will receive up to $5,175 for completing the study. If you choose to enroll, you must spend twenty consecutive nights literally locked in a research facility. You will be told what to eat, when to eat, and when to sleep. You will share a bedroom with several strangers. Who are you, and why would you sign up for this kind of test?
This book explores the hidden world of pharmaceutical testing. Drawing on two years of fieldwork in residential research clinics across the United States and 268 interviews with both volunteers and staff, Jill A. Fisher finds that decisions to enroll in such medical studies are often influenced by poverty, a history of incarceration, or being a member of a minority group who faces social and economic inequalities, and so has limited options for income. She shows that the healthy people who participate in Phase I clinical trials are typically recruited from African American and Latino/a communities and that they are often serial participants who obtain a significant portion of their income from being included in such clinical trials.
Adverse Events thus shows how social inequality fundamentally shapes Phase I trials. Moreover, it shows that participants, in their quest to continue to be picked for inclusion and maintain their income from such trials, form their daily habits in an effort to stay healthy enough to continue to qualify. But in actually improving their health to ensure that they are model volunteers--or in sometimes skirting rules about how long to wait in between trials by moving from clinic to clinic--these serial participants can end up affecting the validity of the trials themselves.
From the often desperate circumstances of serial study participants, to the very validity of these trial results, Fisher explores the social inequalities and less-than-trustworthy findings of medical research in which nearly everybody involved is incentivized to game the system. Adverse Events provides an unprecedented view of the intersection of racial inequalities with pharmaceutical testing, signaling the dangers of this research enterprise to both social justice and public health.
Автор: Sheets, Rebecca Название: Fundamentals of Biologicals Regulation ISBN: 0128092904 ISBN-13(EAN): 9780128092903 Издательство: Elsevier Science Рейтинг: Цена: 19875.00 р. Наличие на складе: Поставка под заказ.
Описание:
Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals.
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