Описание: Intends to define the area of pharmaceutical chemistry as distinct from medicinal chemistry. This book emphasizes on the physicochemical properties of drug molecules and, in so far as they are known, the way that these properties govern the interaction of the drug with its target.
Автор: Alessandra Perri; Enzo Peruffo Название: Family Business and Technological Innovation ISBN: 3319615955 ISBN-13(EAN): 9783319615950 Издательство: Springer Рейтинг: Цена: 7685.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book explores technological innovation in family firms, seeking to reconstruct the links between the heterogeneous dimensions of family businesses and their innovative behaviour.
Автор: Hans-J?rgen B?ssler; Frank Lehmann Название: Containment Technology ISBN: 3662510529 ISBN-13(EAN): 9783662510520 Издательство: Springer Рейтинг: Цена: 11753.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book offers comprehensive coverage on all aspects of containment technology as well as introduces the latest developments in this exciting field.
Автор: Shields, Kristine E. Название: Pregnancy and the Pharmaceutical Industry ISBN: 0128185503 ISBN-13(EAN): 9780128185506 Издательство: Elsevier Science Рейтинг: Цена: 16161.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Pregnancy and the Pharmaceutical Industry: The Movement Toward Evidence-based Care for Pregnant Women explores the issues surrounding the decision to undertake clinical trials with pregnant women. There is currently a lack of data on the safety and effectiveness of medications when they are used during pregnancy, and it is impossible to extrapolate that information from drug studies on men and nonpregnant women. A majority of pregnant women confront a medical condition during their pregnancy, from simple pain to on-going or new medical issues to life-threatening emergencies. New draft guidance from the FDA offers specific recommendations to include pregnant women in drug studies that minimize risk and maximize therapeutic data. This book quantifies the current absence of pregnant women in drug studies and identifies the ethical issues, barriers, and litigation fears, but also the opportunities articulated by physicians, lawyers, ethicists, and other stakeholders in and around the pharmaceutical industry. Pregnancy and the Pharmaceutical Industry: The Movement Toward Evidence-based Care for Pregnant Women explores the views of the pharmaceutical industry on the inclusion of pregnant women in clinical studies, as well as presents information for stakeholders on the ethical rationale, context, and details to adapt to this new FDA guidance. Those in the pharmaceutical industry, IRB members, who approve or deny the drug study plan, doctors, nurses, and midwives working in obstetrics or involved in conducting studies at their institutions will find this book an essential resource.
Explores the medical, ethical, scientific, and legal rationales behind the inclusion of pregnant women in drug studies
Describes how pharma and biotech companies can safely implement the new FDA guidance and begin to include pregnant women in drug testing
Shares views from pharmaceutical industry insiders about company risks, reluctance to implement the guidance, but the ultimate need to include pregnant women in studies
Описание: This book includes all of the theory as well as the practical side of pharmaceutical biochemistry, presented in a simple, yet comprehensive, way. It includes chapters on topics such as biomolecules, biogeneratics, energy rich compounds, biological oxidation, the catalytic role of enzymes, the importance of enzyme inhibitors in the design of new drugs, and therapeutic and diagnostic applications of enzymes.
Описание: Green Sustainable Process for Chemical and Environmental Engineering and Science: Solvents for the Pharmaceutical Industry aims at providing a detailed overview of applications of green solvents in pharmaceutical industries. It also focuses on providing a detailed literature survey on the green solvents for pharmaceutical analysis, drug design, synthesis, and production, etc. It summarizes the applications of various greens solvents such as water, cyrene, vegetable oils, ionic liquids, ethyl lactate, eutectic solvents, and glycerol in contrast to toxic solvents. This book provides an overview of the use of green solvents for the sustainable and environmentally friendly development of synthetic methodologies for biomedical and pharmaceutical industries.
Название: Simulation for Designing Clinical Trials ISBN: 0367395606 ISBN-13(EAN): 9780367395605 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation practices. The book discusses how to design clinical trials according to their probability for success, techniques to define distributions of virtual subjects' characteristics, methods to determine the sensitivity of the trial design, and the population relationship between dosing schedules and patient response.
Автор: Steven P. Millard; Andreas Krause Название: Applied Statistics in the Pharmaceutical Industry ISBN: 144193166X ISBN-13(EAN): 9781441931665 Издательство: Springer Рейтинг: Цена: 21661.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Providing a general guide to statistical methods used in the pharmaceutical industry, and illustrating how to use S-PLUS to implement these methods, the book explains why S-PLUS is a useful software package and discusses the results and implications of each particular application.
Описание: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.
Автор: Christoph Saal, Anita Nair Название: Solubility in Pharmaceutical Chemistry ISBN: 3110545136 ISBN-13(EAN): 9783110545135 Издательство: Walter de Gruyter Цена: 19144.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
This book describes the physicochemical fundamentals and biomedical principles of drug solubility. Methods to study and predict solubility in silico and in vitro are described and the role of solubility in a medicinal chemistry and pharmaceutical industry context are discussed. Approaches to modify and control solubility of a drug during the manufacturing process and of the pharmaceutical product are essential practical aspects of this book.
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration.
Features:
Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product
Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing
Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement
It discusses the advantages of single-use process technologies and the qualification needs
Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs
The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.
Описание: Illustrates the use of systems such as in-process control, quality auditing, and specifications, stressing a troubleshooting, cost-effective approach to product packaging for maximized early lead time to the customer. Addressing the needs of the pharmaceutical industry, the approaches supplied are l
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