Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development, Breitkreitz
Автор: Watson David G. Название: Pharmaceutical Analysis. 5 ed ISBN: 0702078077 ISBN-13(EAN): 9780702078071 Издательство: Elsevier Science Рейтинг: Цена: 5305.00 р. 7578.00-30% Наличие на складе: Есть (5 шт.) Описание: Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of analyses, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals. The mathematics involved is notoriously difficult, but this much-praised textbook, now revised and updated for its fifth edition, guides a student through the complexities with clear writing and the author's expertise from many years' teaching pharmacy students. Two new chapters have been added to the new edition covering methods used in the quality control of biotechnologically produced drugs, and electrochemical biosensors. There is continuous learning reinforcement throughout the book by way of worked calculation examples and self-assessment test questions. Worked calculation examples Self-assessment Additional problems (self tests) Practical boxes Key points boxes Two new chapters: Chapter 16 Methods used in the quality control of biotechnologically produced drugs Chapter 17 Electrochemical biosensors
Описание: A comprehensive introduction to inorganic chemistry and, specifically, the science of metal-based drugs, Essentials of Inorganic Chemistry describes the basics of inorganic chemistry, including organometallic chemistry and radiochemistry, from a pharmaceutical perspective.
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.
Описание: Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of analyses, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals.
The mathematics involved is notoriously difficult, but this much-praised textbook, now revised and updated for its fifth edition, guides a student through the complexities with clear writing and the author's expertise from many years' teaching pharmacy students. Two new chapters have been added to the new edition covering methods used in the quality control of biotechnologically produced drugs, and electrochemical biosensors. There is continuous learning reinforcement throughout the book by way of worked calculation examples and self-assessment test questions.
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: Leblanc Destin A Название: Validated Cleaning Technologies For Pharmaceutical Manufacturing ISBN: 1574911163 ISBN-13(EAN): 9781574911169 Издательство: Taylor&Francis Рейтинг: Цена: 33686.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Written by an expert especially for those who must design validatable cleaning processes and then must validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning process fits into the validation program, making it more defensible in both internal quality audits and external regulatory audits. Designed for use in the overall validation program, the book demonstrates how to build a comprehensive program, and includes discussion and examples of cleaning systems, regulatory requirements, and special topics and issues. It provides an FDA cleaning validation guidance document and a comprehensive glossary.
Автор: Alok K. Kulshreshtha; Onkar N. Singh; G. Michael W Название: Pharmaceutical Suspensions ISBN: 1489984178 ISBN-13(EAN): 9781489984173 Издательство: Springer Рейтинг: Цена: 27950.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system – poorly soluble active pharmaceutical ingredients s- pended in a suitable vehicle.
Автор: Alok K. Kulshreshtha; Onkar N. Singh; G. Michael W Название: Pharmaceutical Suspensions ISBN: 1441910867 ISBN-13(EAN): 9781441910868 Издательство: Springer Рейтинг: Цена: 26122.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Pharmaceutical Suspensions describes the fundamentals and theoretical concepts of disperse systems. Readers will find a discussion of the development of pharmaceutical suspensions, in addition to nano-suspensions, an emerging area within the field.
Автор: Ostrove, Steven Название: Ostrove - Equipment Qualification in the Pharmaceutical Industry ISBN: 0128175680 ISBN-13(EAN): 9780128175682 Издательство: Elsevier Science Рейтинг: Цена: 16505.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems.
Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.
Incorporates good manufacturing processes into a compliant qualification program
Provides examples of protocol layout
Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume One, Compressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this first volume of a six-volume set, compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
Описание: The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Two, Uncompressed Solid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing.
ООО "Логосфера " Тел:+7(495) 980-12-10 www.logobook.ru
