Preformulation in Solid Dosage Form Development, Adeyeye, Moji Christianah
Автор: Niazi, Sarfaraz K. Название: Handbook of Preformulation ISBN: 1032338474 ISBN-13(EAN): 9781032338477 Издательство: Taylor&Francis Рейтинг: Цена: 7808.00 р. Наличие на складе: Нет в наличии.
Автор: Qiu, Yihong Название: Developing Solid Oral Dosage Forms ISBN: 012802447X ISBN-13(EAN): 9780128024478 Издательство: Elsevier Science Рейтинг: Цена: 39582.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations.
This book covers the essential principles of physical pharmacy, biopharmaceutics, and industrial pharmacy, and their application to the research and development process of oral dosage forms. Chapters have been added, combined, deleted, and completely revised as necessary to produce a comprehensive, well-organized, valuable reference for industry professionals and academics engaged in all aspects of the development process.
New and important topics include spray drying, amorphous solid dispersion using hot-melt extrusion, modeling and simulation, bioequivalence of complex modified-released dosage forms, biowaivers, and much more.
Written and edited by an international team of leading experts with experience and knowledge across industry, academia, and regulatory settings
Includes new chapters covering the pharmaceutical applications of surface phenomenon, predictive biopharmaceutics and pharmacokinetics, the development of formulations for drug discovery support, and much more
Presents new case studies throughout, and a section completely devoted to regulatory aspects, including global product regulation and international perspectives
Автор: Mittal, Bhavishya Название: How to Develop Robust Solid Oral Dosage Forms from Conception to ISBN: 0128047313 ISBN-13(EAN): 9780128047316 Издательство: Elsevier Science Рейтинг: Цена: 8588.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips.
By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms.
Автор: Pandey, Preetanshu Название: Modeling of Pharmaceutical Unit Operations in Solid Dosage Forms ISBN: 0081001541 ISBN-13(EAN): 9780081001547 Издательство: Elsevier Science Рейтинг: Цена: 24423.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Qualityby Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included.
Автор: Vergnaud Название: Controlled Drug Release Of Oral Dosage Forms ISBN: 0131749544 ISBN-13(EAN): 9780131749542 Издательство: Taylor&Francis Рейтинг: Цена: 56654.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: A practical guide which explains how to carry out the numerical analysis of matter transfer - a vital process when examining the formulation of oral dosage forms with controlled drug release. The author models the process of drug delivery using numerical analysis and computerization.
Автор: Lieberman Herbert Название: Pharmaceutical Dosage Forms: Tablets: Vol 3 ISBN: 082478300X ISBN-13(EAN): 9780824783006 Издательство: Informa Цена: 14615.00 р. Наличие на складе: Нет в наличии.
Автор: Lieberman Herbert Название: Pharmaceutical Dosage Forms: Tablets: Vol 1 ISBN: 0824780442 ISBN-13(EAN): 9780824780449 Издательство: Informa Цена: 14615.00 р. Наличие на складе: Нет в наличии.
Описание: A reference compendium for professionals working in tablet making, this three-volume set provides essential information on solid dosage forms and discusses the processes employed in manufacturing, bioavailability, and compression tooling. It is a key resource for undergraduate and graduate students in pharmacy as well as a reference for product development, hospital pharmacists, and regulatory personnel. It has been called "the best and most complete in the field" by the Journal of Controlled Release.
Автор: Lieberman Herbert Название: Pharmaceutical Dosage Forms: Disperse Systems: V. 2 ISBN: 0824797132 ISBN-13(EAN): 9780824797133 Издательство: Taylor&Francis Рейтинг: Цена: 17558.00 р. Наличие на складе: Нет в наличии.
Описание: This outstanding Second Edition of an indispensable reference text concentrates on specific types of disperse system dosage forms, including methods of formulation and stability test procedures.
Автор: Beverly Nickerson Название: Sample Preparation of Pharmaceutical Dosage Forms ISBN: 148999582X ISBN-13(EAN): 9781489995827 Издательство: Springer Рейтинг: Цена: 24392.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.
Автор: Sumie Yoshioka; Valentino J. Stella Название: Stability of Drugs and Dosage Forms ISBN: 1475786727 ISBN-13(EAN): 9781475786729 Издательство: Springer Рейтинг: Цена: 19377.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Drug products are complex mixtures of drugs and excipients and, as such, their chemical and physical stability kinetics are complex. The book is intended for graduate students, researchers and professionals in the field of Pharmaceutics and Pharmaceutical Chemistry.
Название: Development of biopharmaceutical parenteral dosage forms ISBN: 036740091X ISBN-13(EAN): 9780367400910 Издательство: Taylor&Francis Рейтинг: Цена: 10411.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms
details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process
describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization
considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance
elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity
shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends
reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications
and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable
Название: Semisolid Dosage ISBN: 3039369482 ISBN-13(EAN): 9783039369485 Издательство: Неизвестно Рейтинг: Цена: 8151.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Even in ancient times, semi-solid preparations for cutaneous application, popularly known as ointments, played an important role in human society. An advanced scientific investigation of "ointments" as dosage forms was initiated in the 1950s. It was only from then on that the intensive physico-chemical characterization of ointments as well as the inclusion of dermatological aspects led to a comprehensive understanding of the various interactions between the vehicle, the active ingredient and the skin. From then on, many researchers were involved in optimizing semi-solid formulations with respect to continuously changing therapeutic and patient needs. Aspects that have been dealt with were the optimization of dermato-biopharmaceutical properties and many different issues related to patient compliance, such as skin tolerance, applicability, and cosmetic appeal. Moreover, processing technology has been improved and analytical techniques were developed and refined in order to enable the improved characterization of the formulation itself as well as its interaction with the skin. This Special Issue serves to highlight and capture the contemporary progress and current research on semi-solid formulations as dermal drug delivery systems. We invite articles on all aspects of semi-solid formulations, highlighting the research currently undertaken to improve and better understand these complex drug delivery systems with respect to their formulation, processing and characterization issues.
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