Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.
Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof.
Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms.
The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.
Автор: Alfredo Ulloa-Aguirre; Ya-Xiong Tao Название: Targeting Trafficking in Drug Development ISBN: 3030089274 ISBN-13(EAN): 9783030089276 Издательство: Springer Рейтинг: Цена: 204040.00 T Наличие на складе: Поставка под заказ. Описание: Cellular trafficking is only recently identified as a site for therapeutic intervention. This book provides up to date information on the mechanism for exploiting this area for drug development as well as a clear understanding of the individual components of cellular trafficking. The authors are experts in their areas and the book features tables and figures that enable comparison and clear understanding.
Автор: Laszlo Endrenyi and Dr. Paul Declerck Название: Biosimilar Drug Product Development ISBN: 1498718795 ISBN-13(EAN): 9781498718790 Издательство: Taylor&Francis Рейтинг: Цена: 183750.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Автор: Kerry B. Barker, Sandeep M. Menon, Ralph B. D`Agostino, Siyan Xu, Bo Jin Название: Biosimilar Clinical Development: Scientific Considerations and New Methodologies ISBN: 1482231697 ISBN-13(EAN): 9781482231694 Издательство: Taylor&Francis Рейтинг: Цена: 132710.00 T Наличие на складе: Нет в наличии. Описание: Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.
Автор: Steven Kanner Название: Tumor Metabolome Targeting and Drug Development ISBN: 146149544X ISBN-13(EAN): 9781461495444 Издательство: Springer Рейтинг: Цена: 156720.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: In this volume, the major metabolic alterations identified in cancer and tumor-associated cells are explored, including discussions of former and emerging approaches to drug development in targeting cancer cell metabolism.
Автор: Jose das Neves Название: Drug Delivery and Development of Anti-HIV Microbicides ISBN: 9814463566 ISBN-13(EAN): 9789814463560 Издательство: Taylor&Francis Рейтинг: Цена: 193950.00 T Наличие на складе: Невозможна поставка. Описание:
The worldwide impact of HIV/AIDS is well recognized. This book provides for the first time a thorough and critical overview of current aspects, recent developments, and trends in the formulation and drug delivery concerning anti-HIV microbicides by leading scientists in the field. Additionally, pertinent regulatory aspects and socioeconomical issues related to the subject are discussed. In the absence of a cure, prophylaxis represents a cornerstone in the battle against infection. One promising strategy comprises the use around the time of sexual intercourse of vaginal/rectal products containing antiviral compounds, termed microbicides. It is now recognized that specific development of drug dosage forms and/or drug delivery systems is an indispensable aspect for the success of microbicides. Different groups strived over the last decade to optimize the biophysical and technological performance of traditional dosage forms (gels, tablets, and suppositories) to fulfill the specificities of microbicides use, without neglecting users' preferences and affordability issues. Moreover, new formulation approaches, such as vaginal rings and films, nanotechnology-based systems, stimuli-sensitive formulations, targeted drug delivery systems, among others have been proposed and are currently undergoing pre-clinical or even clinical testing.
Автор: Steven Kanner Название: Tumor Metabolome Targeting and Drug Development ISBN: 1493953435 ISBN-13(EAN): 9781493953431 Издательство: Springer Рейтинг: Цена: 130590.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: In this volume, the major metabolic alterations identified in cancer and tumor-associated cells are explored, including discussions of former and emerging approaches to drug development in targeting cancer cell metabolism.
This book offers a much-needed discussion on the targeting of biofilm-related infections. Chapters include discussions on the impact of biofilm on medical implants, industrial applications, as well as wound and tissue infections. It also offers discussions on regulatory management for industrial sectors and medical environments. Given that there continues to be a paucity of effective antimicrobial products, devices, and coatings in clinical and industrial use that effectively reduce rates of infection or biofilm-related problems, Targeting Biofilms in Translational Research, Device Development, and Industrial Sectors, offers a fresh and much-needed perspective aimed at helping create healthier controlled environments and safer devices.
This comprehensive book is indispensable for industrial and academic translational researchers, device developers, and regulatory experts looking to create more effective antimicrobial products.
Автор: Nikolaos E. Labrou Название: Targeting Enzymes for Pharmaceutical Development ISBN: 1071601628 ISBN-13(EAN): 9781071601624 Издательство: Springer Рейтинг: Цена: 111790.00 T Наличие на складе: Поставка под заказ. Описание: This volume explores detailed methods and experimental protocols evaluating the effect of a compound or a mixture of compounds on the action of enzymes that are significant targets in pharmaceuticals. Consisting of three sections, the book delves into recent biocomputing and bioinformatics protocols, state-of-the art modern biophysical, electrophoretic, and chromatographic methods and high-throughput screening approaches, as well as detailed protocols and examples of the inhibition analysis and evaluation of selected enzymes. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls.
Authoritative and cutting-edge, Targeting Enzymes for Pharmaceutical Development: Methods and Protocols serves as a vital reference for academics and industry professionals working on expanding our understanding of the wide range of important enzyme targets.
Автор: Liu Название: Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development ISBN: 1118662318 ISBN-13(EAN): 9781118662311 Издательство: Wiley Рейтинг: Цена: 171020.00 T Наличие на складе: Поставка под заказ. Описание: Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
Автор: Held, Jr Название: Deep Homology? ISBN: 1316601218 ISBN-13(EAN): 9781316601211 Издательство: Cambridge Academ Рейтинг: Цена: 40120.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book provides a comparison of the genetic circuits of Homo sapiens and Drosophila melanogaster to reveal the evidence for deep homology, from the field of evolutionary developmental biology. Individual body parts including the nervous system, limbs and heart are compared in chapters that also feature concept maps and encyclopaedic tables to aid learning.
Автор: Indra K. Reddy, Reza Mehvar Название: Chirality in Drug Design and Development ISBN: 0824750624 ISBN-13(EAN): 9780824750626 Издательство: Taylor&Francis Рейтинг: Цена: 265410.00 T Наличие на складе: Невозможна поставка. Описание:
Covering every essential element in the development of chiral products, this reference provides a solid overview of the formulation, biopharmaceutical characteristics, and regulatory issues impacting the production of these pharmaceuticals. It supports researchers as they evaluate the pharmacodynamic, pharmacokinetic, and toxicological characteristics of specific enantiomers and chiral drug compounds and addresses in one convenient reference all the major challenges pertaining to drug chirality that have been neglected in the literature. Chirality in Drug Design and Development collects the latest studies from an interdisciplinary team of experts on chiral drug design.
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