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The Role of Microstructure in Topical Drug Product Development, Nigel Langley; Bozena Michniak-Kohn; David W. Osbo


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Автор: Nigel Langley; Bozena Michniak-Kohn; David W. Osbo
Название:  The Role of Microstructure in Topical Drug Product Development
ISBN: 9783030173548
Издательство: Springer
Классификация:



ISBN-10: 3030173542
Обложка/Формат: Hardcover
Страницы: 199
Вес: 0.46 кг.
Дата издания: 2019
Серия: AAPS Advances in the Pharmaceutical Sciences Series
Язык: English
Издание: 1st ed. 2019
Иллюстрации: 25 tables, color; 55 illustrations, color; 47 illustrations, black and white; viii, 199 p. 102 illus., 55 illus. in color.
Размер: 164 x 244 x 16
Читательская аудитория: Professional & vocational
Основная тема: Biomedicine
Ссылка на Издательство: Link
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Поставляется из: Германии
Описание: Following the Semi-solid Microstructure Workshop sponsored by BASF and hosted by the Rutgers Center for Dermal Research, a pharmaceutical product development working group was formed. The group, known as the Q3 Working Group, selected the following five areas of focus: Particle/Globule Size and Distribution, Viscosity/Rheology/Spreadability, In Vitro Testing, State of API, State of Excipients. A committee was appointed for each of these five areas. The committees were tasked to review the literature, identify best practices, list experimental details required for an independent lab to duplicate the test, and propose scientific studies that may meaningfully advance this specific area of focus. Each committee has a chair (or co-chairs) that are the lead author(s) of the chapter. The Q3 Working Group members serve as the critical reviewers of each chapter, making suggestions that improve the quality of the document and that make each of the five chapters uniform in scope and content.
Pharmaceutical development scientists that formulate topical products (creams, lotions, gels suspensions, foams, etc) and all the allied raw material suppliers, packaging suppliers, contract laboratories including CROs, CMOs and regulators need access to this book. Overall, the topic of semisolid microstructure is of equal importance to the generic pharmaceutical companies (filing Abbreviated New Drug Applications or ANDAs) and pharmaceutical companies filing New Drug Applications (NDAs). In addition to products applied to the skin, hair, and nails, The Role of Microstructure in Topical Drug Product Development’ crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments and gels, otic suspension, vaginal semisolids and retention enemas.

Дополнительное описание: Part I - Critical Quality Attributes: 1. Rheological Characterization in the Development of Topical Drug Products.- 2. In Vitro Release & Permeation Tests as Critical Quality Attributes in Topical Product Development.- 3. Determination of Particle Size an



Dispersion Stability, Microstructure and Phase Transition of Anisotropic Nanodiscs

Автор: Ravi Kumar Pujala
Название: Dispersion Stability, Microstructure and Phase Transition of Anisotropic Nanodiscs
ISBN: 3319381954 ISBN-13(EAN): 9783319381954
Издательство: Springer
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Цена: 13059.00 р.
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Описание: Recognized as an outstanding contribution to the field, this thesis is a comprehensive exploration of physical phenomena in nano clay systems. It features the author`s data on the first experimental observation of a system with high aspect ratio nanodiscs.

Biosimilar Drug Product Development

Автор: Laszlo Endrenyi and Dr. Paul Declerck
Название: Biosimilar Drug Product Development
ISBN: 1498718795 ISBN-13(EAN): 9781498718790
Издательство: Taylor&Francis
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Цена: 27562.00 р.
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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.

Continuous Media with Microstructure

Автор: Bettina Albers
Название: Continuous Media with Microstructure
ISBN: 364242564X ISBN-13(EAN): 9783642425646
Издательство: Springer
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Цена: 29209.00 р.
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Описание: This book discusses the extension of classical continuum models. To the first class addressed belong various thermodynamic models of multicomponent systems, and to the second class belong primarily microstructures created by phase transformations.

Image Analysis of Food Microstructure

Автор: Russ, John C.
Название: Image Analysis of Food Microstructure
ISBN: 036739359X ISBN-13(EAN): 9780367393595
Издательство: Taylor&Francis
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Цена: 9798.00 р.
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Описание:

Image Analysis of Food Microstructure offers a condensed guide to the most common procedures and techniques by which quantitative microstructural information about food can be obtained from images. The images are selected from a broad range of food items, including macroscopic images of meat and finished products such as pizza, and the microstructures of cheeses, dough and baked goods, ice cream, fruits and vegetables, emulsions, foams, and gels.

The book informs food scientists about the image processing and measurement tools used to characterize a variety of microstructures in foods, using high-quality image techniques to illustrate chemical composition, thermo-mechanical processing, and genetic and structural properties. These different types of images used to measure various aspects of structure include: macroscopic light photography, confocal light microscopy, electron microscopy, atomic force microscope images, magnetic resonance, and computed tomography. Then the text explains how to interpret images to produce data, plot the results in different graphs, and identify trends. Examples using these image analysis techniques show typical results that researchers can expect and recreate.

Image Analysis of Food Microstructure summarizes the basic procedures that can be useful in various aspects of food research, from nutraceuticals to cooking and food processing. It presents the processing of images and mathematical principles needed for image analyses in a step-by-step approach to extract key information from the images obtained.

Diffraction Analysis of the Microstructure of Materials

Автор: Eric J. Mittemeijer; Paolo Scardi
Название: Diffraction Analysis of the Microstructure of Materials
ISBN: 3642073522 ISBN-13(EAN): 9783642073526
Издательство: Springer
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Цена: 32651.00 р.
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Описание: Overview of diffraction methods applied to the analysis of the microstructure of materials.

Dispersion Stability, Microstructure and Phase Transition of Anisotropic Nanodiscs

Автор: Ravi Kumar Pujala
Название: Dispersion Stability, Microstructure and Phase Transition of Anisotropic Nanodiscs
ISBN: 3319045547 ISBN-13(EAN): 9783319045542
Издательство: Springer
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Цена: 18167.00 р.
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Описание: Recognized as an outstanding contribution to the field, this thesis is a comprehensive exploration of physical phenomena in nano clay systems. It features the author`s data on the first experimental observation of a system with high aspect ratio nanodiscs.

Topical antimicrobials testing and evaluation

Автор: Paulson, Daryl S.
Название: Topical antimicrobials testing and evaluation
ISBN: 036737787X ISBN-13(EAN): 9780367377878
Издательство: Taylor&Francis
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Цена: 9798.00 р.
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Описание:

A range of factors must be considered when developing a topical antimicrobial for use in a healthcare personnel handwash, surgical scrub, or preoperative skin preparation. Antimicrobial effectiveness, low skin irritation, ease of use, and pleasing aesthetics are all essential if the product is to succeed. In addition, all facets of the product must comply with stringent regulatory requirements. With updated protocols and research, Topical Antimicrobials Testing and Evaluation, Second Edition comprehensively presents and reviews the latest techniques for testing antimicrobial compounds for effectiveness and regulatory compliance.



Topics include:







  • The anatomical structure of the skin and skin microbiology relevant to product testing






  • Use of antimicrobial products against specific microorganisms such as Staphylococcus and Streptococcus species






  • Measurement of antimicrobial action of topical antimicrobials from experimental design, microbiological, biostatistical, and marketplace perspectives






  • Various aspects of the topical antimicrobial products currently in common use in medical, food service, and consumer markets






  • Statistical analysis and specific statistical designs for clinical trials






  • Epistemological requirements in evaluating the effects of specific treatments






  • Evaluation strategies and sample working protocols for hand and body soaps, food-handler antimicrobial products, and medical/healthcare industry antimicrobial products




The book is designed to inform industry and academia on the requirements to get products approved by the FDA and to market while also providing critical insight on ways to best service expanding markets.

Pharmaceutical Drug Product Development and Process Optimization

Название: Pharmaceutical Drug Product Development and Process Optimization
ISBN: 1771888725 ISBN-13(EAN): 9781771888721
Издательство: Taylor&Francis
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Цена: 20059.00 р.
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Описание: This volume presents and discusses the vital precepts underlying the efficient, effective, and cost-effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development.


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