Approved Drug Products With Therapeutic Equivalence Evaluations Fda Orange Book 30th Edition 2010 - [PDF] Full eBook Download

Excipient Applications in Formulation Design and Drug Delivery

Author : Ajit S Narang,Sai H S. Boddu

ISBN10 : 3319202065

Publisher : Springer

Number of Pages : 681

Category : Medical

Viewed : 855

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Book Summary: In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.

Biosimilarity

Author : Sarfaraz K. Niazi

ISBN10 : 1498750400

Publisher : CRC Press

Number of Pages : 398

Category : Medical

Viewed : 1176

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Book Summary: Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars. Features: First comprehensive analysis based on new guidelines and approval packages of several biosimilars Presents the first approach to challenge FDA in reducing or eliminating any testing in patients. Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars

The European Blood and Marrow Transplantation Textbook for Nurses

Author : Michelle Kenyon,Aleksandra Babic

ISBN10 : 3319500260

Publisher : Springer

Number of Pages : 311

Category : Medical

Viewed : 665

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Book Summary: This book is open access under a CC BY 4.0 license. This textbook, endorsed by the European Society for Blood and Marrow Transplantation (EBMT), provides adult and paediatric nurses with a full and informative guide covering all aspects of transplant nursing, from basic principles to advanced concepts. It takes the reader on a journey through the history of transplant nursing, including essential and progressive elements to help nurses improve their knowledge and benefit the patient experience, as well as a comprehensive introduction to research and auditing methods. This new volume specifically intended for nurses, complements the ESH-EBMT reference title, a popular educational resource originally developed in 2003 for physicians to accompany an annual training course also serving as an educational tool in its own right. This title is designed to develop the knowledge of nurses in transplantation. It is the first book of its kind specifically targeted at nurses in this specialist field and acknowledges the valuable contribution that nursing makes in this area. This volume presents information that is essential for the education of nurses new to transplantation, while also offering a valuable resource for more experienced nurses who wish to update their knowledge.

Handbook of Drug Interactions

Author : Ashraf Mozayani,Lionel Raymon

ISBN10 : 1592596541

Publisher : Springer Science & Business Media

Number of Pages : 663

Category : Medical

Viewed : 1342

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Book Summary: A concise compilation of the known interactions of the most commonly prescribed drugs, as well as their interaction with nonprescription compounds. The agents covered include CNS drugs, cardiovascular drugs, antibiotics, and NSAIDs. For each class of drugs the authors review the pharmacology, pharmacodynamics, pharmacokinetics, chemistry, metabolism, epidemiological occurrences, adverse reactions, and significant interactions. Environmental and social pharmacological issues are also addressed in chapters on food and alcohol drug interactions, nicotine and tobacco, and anabolic doping agents. Comprehensive and easy-to-use, Handbook of Drug Interactions: A Clinical and Forensic Guide provides physicians with all the information needed to avoid prescribing drugs with undesirable interactions, and toxicologists with all the data necessary to interpret possible interactions between drugs found simultaneously in patient samples.

Patient Assessment in Clinical Pharmacy

Author : Sherif Hanafy Mahmoud

ISBN10 : 3030117758

Publisher : Springer

Number of Pages : 439

Category : Medical

Viewed : 1685

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Book Summary: This comprehensive, first-of-its kind title is an indispensable resource for pharmacists looking to learn or improve crucial patient assessment skills relevant to all pharmacy practice settings. Pharmacists’ role as health care practitioners is evolving as they are taking a more active part in primary patient care -- helping patients manage their medications and diseases, providing patient education, and, in some jurisdictions, prescribing and adapting medications. To perform their day-to-day duties, pharmacists are best-served using a framework called the patient care process. This framework involves three steps: patient assessment; care plan development and implementation; and monitoring and follow up. Organized in four parts, this practical book begins with introductory chapters regarding the basics of patient assessment and the patient care process. Part II includes a detailed assessment of common symptoms encountered by pharmacists. Part III discusses assessment of patients with various chronic illnesses. Part IV addresses select specialized topics and assessment considerations. An invaluable contribution to the literature, Patient Assessment in Clinical Pharmacy: A Comprehensive Guide will be of great benefit to pharmacists, regardless of their practice setting, and to pharmacy students as well.

The Health Effects of Cannabis and Cannabinoids

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Population Health and Public Health Practice,Committee on the Health Effects of Marijuana: An Evidence Review and Research Agenda

ISBN10 : 0309453070

Publisher : National Academies Press

Number of Pages : 486

Category : Science

Viewed : 1936

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Book Summary: Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk. However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively. Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agendaâ€"outlining gaps in current knowledge and opportunities for providing additional insight into these issuesâ€"that summarizes and prioritizes pressing research needs.

Albumin in Medicine

Author : Masaki Otagiri,Victor Tuan Giam Chuang

ISBN10 : 9811021163

Publisher : Springer

Number of Pages : 277

Category : Medical

Viewed : 423

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Book Summary: This book presents a comprehensive overview of medical and pharmaceutical applications of human serum albumin (HSA), with updates on structural aspects of albumin from the perspectives of X-ray crystallography and NMR, endogenous and exogenous ligand binding of albumin in various pathological conditions, and genetic variants and their phenotypes. Rapid progress and development of its applications have resulted in outstanding results for which albumin has clearly been proven to be a robust biomaterial. Contributions from leading international experts in this field show how HSA is applied to diagnosis, therapy, drugs, and treatment, with a comprehensive introduction of HSA. This volume will appeal to scientists in pharmaceutical and medical research including pharmaceutical chemists, pharmacokineticists, toxicologists, and biochemists not only in academia but also in industry. Readers can effectively acquire the most recent knowledge of applications of HSA and its impact on human health in a single volume.

The EBMT Handbook

Author : Enric Carreras,Carlo Dufour,Mohamad Mohty,Nicolaus Kröger

ISBN10 : 3030022781

Publisher : Springer

Number of Pages : 702

Category : Medical

Viewed : 722

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Book Summary: This Open Access edition of the European Society for Blood and Marrow Transplantation (EBMT) handbook addresses the latest developments and innovations in hematopoietic stem cell transplantation and cellular therapy. Consisting of 93 chapters, it has been written by 175 leading experts in the field. Discussing all types of stem cell and bone marrow transplantation, including haplo-identical stem cell and cord blood transplantation, it also covers the indications for transplantation, the management of early and late complications as well as the new and rapidly evolving field of cellular therapies. This book provides an unparalleled description of current practices to enhance readers’ knowledge and practice skills.

Intellectual Property and Health Technologies

Author : Joanna T. Brougher

ISBN10 : 146148202X

Publisher : Springer Science & Business Media

Number of Pages : 214

Category : Medical

Viewed : 810

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Book Summary: Intellectual Property and Health Technologies Balancing Innovation and the Public's Health Joanna T. Brougher, Esq., MPH At first glance, ownership of intellectual property seems straightforward: the control over an invention or idea. But with the recent explosion of new scientific discoveries poised to transform public health and healthcare systems, costly and lengthy patent disputes threaten both to undermine the attempts to develop new medical technologies and to keep potentially life-saving treatments from patients who need them. Intellectual Property and Health Technologies grounds readers in patent law and explores how scientific research and enterprise are evolving in response. Geared specifically to the medical disciplines, it differentiates among forms of legal protection for inventors such as copyrights and patents, explains their limits, and argues for balance between competing forces of exclusivity and availability. Chapters delve into the major legal controversies concerning medical and biotechnologies in terms of pricing, markets, and especially the tension between innovation and access, including: The patent-eligibility of genes The patent-eligibility of medical process patents The rights and roles of universities and inventors The balancing of access, innovation, and profit in drug development The tension between biologics, small-molecule drugs, and their generic counterparts International patent law and access to medicine in the developing world As these issues continue to shape and define the debate, Intellectual Property and Health Technologies enables professionals and graduate students in public health, health policy, healthcare administration, and medicine to understand patent law and how it affects the development of medical technology and the delivery of medicine.

Delivering Superior Health and Wellness Management with IoT and Analytics

Author : Nilmini Wickramasinghe,Freimut Bodendorf

ISBN10 : 303017347X

Publisher : Springer Nature

Number of Pages : 677

Category : Medical

Viewed : 967

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Book Summary: This in-depth book addresses a key void in the literature surrounding the Internet of Things (IoT) and health. By systematically evaluating the benefits of mobile, wireless, and sensor-based IoT technologies when used in health and wellness contexts, the book sheds light on the next frontier for healthcare delivery. These technologies generate data with significant potential to enable superior care delivery, self-empowerment, and wellness management. Collecting valuable insights and recommendations in one accessible volume, chapter authors identify key areas in health and wellness where IoT can be used, highlighting the benefits, barriers, and facilitators of these technologies as well as suggesting areas for improvement in current policy and regulations. Four overarching themes provide a suitable setting to examine the critical insights presented in the 31 chapters: Mobile- and sensor-based solutions Opportunities to incorporate critical aspects of analytics to provide superior insights and thus support better decision-making Critical issues around aspects of IoT in healthcare contexts Applications of portals in healthcare contexts A comprehensive overview that introduces the critical issues regarding the role of IoT technologies for health, Delivering Superior Health and Wellness Management with IoT and Analytics paves the way for scholars, practitioners, students, and other stakeholders to understand how to substantially improve health and wellness management on a global scale.

Handbook of Food-Drug Interactions

Author : Beverly McCabe-Sellers,Eric H. Frankel,Jonathan J. Wolfe

ISBN10 : 1135504571

Publisher : CRC Press

Number of Pages : 584

Category : Medical

Viewed : 1016

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Book Summary: With contributions from the fields of pharmacy, dietetics, and medicine, Handbook of Food-Drug Interactions serves as an interdisciplinary guide to the prevention and correction of negative food-drug interactions. Rather than simply list potential food-drug interactions, this book provides explanations and gives specific recommendations based on th

Tattooed Skin and Health

Author : J. Serup,N. Kluger,W. Bäumler

ISBN10 : 3318027774

Publisher : Karger Medical and Scientific Publishers

Number of Pages : 258

Category : Medical

Viewed : 1095

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Book Summary: With about 10–20% of the adult population in Europe being tattooed, there is a strong demand for publications discussing the various issues related to tattooed skin and health. Until now, only a few scientific studies on tattooing have been published. This book discusses different aspects of the various medical risks associated with tattoos, such as allergic reactions from red tattoos, papulo-nodular reactions from black tattoos as well as technical and psycho-social complications, in addition to bacterial and viral infections. Further sections are dedicated to the composition of tattoo inks, and a case is made for the urgent introduction of national and international regulations. Distinguished authors, all specialists in their particular fields, have contributed to this publication which provides a comprehensive view of the health implications associated with tattooing. The book covers a broad range of topics that will be of interest to clinicians and nursing staff, toxicologists and regulators as well as laser surgeons who often face the challenge of having to remove tattoos, professional tattooists and producers of tattoo ink.