Computer-Aided Applications In Pharmaceutical Technology, Duris,Jelena
Новое издание
Автор: Duris,Jelena Название: Computer-Aided Applications In Pharmaceutical Technology ISBN: 0443186553 ISBN-13(EAN): 9780443186554 Издательство: Elsevier Science Цена: 21896.00 р. Наличие на складе: Есть у поставщикаПоставка под заказ.
Автор: Shah B. Название: Textbook Of Pharmacognosy And Phytochemistry 2Ed ISBN: 9386217732 ISBN-13(EAN): 9789386217738 Издательство: CBS India Рейтинг: Цена: 5487.00 р. 7838.00-30% Наличие на складе: Есть (1 шт.)
How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control.
With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.
Discusses the development of strategy blueprints in the design of continuous processes
Shows how to create process flowsheet models from individual unit operation models
Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases
Covers the evolving regulatory expectations for continuous manufacturing
Provides readers with ways to more effectively navigate these expectations
Автор: Joseph P. Stalder Название: Project management for drug developers / ISBN: 103212668X ISBN-13(EAN): 9781032126685 Издательство: Taylor&Francis Рейтинг: Цена: 13320.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry. The text details the role of project managers in drug development, the key interfaces throughout drug development, and tools of the trade.
Автор: Mullaicharam Bhupathyraaj, K. Reeta Vijaya Rani, Musthafa Mohamed Essa Название: Artificial intelligence in Pharmaceutical Sciences ISBN: 103236386X ISBN-13(EAN): 9781032363868 Издательство: Taylor&Francis Рейтинг: Цена: 16078.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Lawrence X. Yu; Bing V. Li Название: FDA Bioequivalence Standards ISBN: 1493955586 ISBN-13(EAN): 9781493955589 Издательство: Springer Рейтинг: Цена: 17074.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
.- 1 Bioequivalence History
.- Alex Yu, Duxin Sun, Bing Li, and Lawrence X. Yu
.- 2 Fundamentals of Bioequivalence
.- Mei-Ling Chen
.- 3 Basic Statistical Considerations
.- Fairouz T. Makhlouf, Stella C. Grosser, Donald J. Schuirmann
.- 4 The Effects of Food on Drug Bioavailability and Bioequivalence
.- Wayne I. DeHaven and Dale P. Conner
.- 5 Biowaiver and Biopharmaceutics Classification System
.- Ramana S. Uppoor, Jayabharathi Vaidyanathan, Mehul Mehta, and Lawrence X. Yu
.- 6 Bioequivalence of Highly Variable Drugs
.- Barbara M. Davit and Devvrat T. Patel
.- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments
.- Hao Zhu, Ramana Uppoor, Mehul Mehta, and Lawrence X. Yu
.- 8 Bioequivalence for Narrow Therapeutic Index Drugs
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: Merkus Название: Particles and Nanoparticles in Pharmaceutical Products ISBN: 3319941739 ISBN-13(EAN): 9783319941738 Издательство: Springer Рейтинг: Цена: 14025.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This edited volume brings together the expertise of numerous specialists on the topic of particles - their physical, chemical, pharmacological and toxicological characteristics - when they are a component of pharmaceutical products and formulations.
Автор: Koulov, Atanas Название: Surfactants in Biopharmaceutical Development ISBN: 0128125039 ISBN-13(EAN): 9780128125038 Издательство: Elsevier Science Рейтинг: Цена: 22738.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Surfactants in Biopharmaceutical Development addresses the progress, challenges and opportunities for surfactant research specific to pharmaceutical development, providing a broad range of important surfactant-related topics as they relate directly to the biopharmaceutical process. Chapters address fundamental topics, like mechanisms of protein stabilization by surfactants, the latest, state-of-the-art technology and methods to illustrate the practical application to biopharmaceutical development, forward-looking chapters on control strategies and novel surfactants, with a special focus on current regulatory aspects of paramount importance for biopharmaceutical companies and regulators.
It has been widely recognized that surfactants provide protection to therapeutic proteins against interfacial stresses. Despite the fact that the very mechanism of protein stabilization by surfactants has not been completely understood, surfactants are universally regarded as critical functional excipients by the industry and by regulators.
Describes the current state of research on surfactants, drawing upon contributions from international experts across industry and academia
Addresses the opportunities and challenges associated with surfactants in drug development and delivery
Provides a defining resource for practitioners in the biopharmaceutical industry, regulators and academics
Summarizes the latest knowledge of surfactants in biopharmaceutical development in one comprehensive volume
Автор: Daan J.A. Crommelin; Jon S. B. de Vlieger Название: Non-Biological Complex Drugs ISBN: 3319358510 ISBN-13(EAN): 9783319358512 Издательство: Springer Рейтинг: Цена: 15957.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs).
Описание: The 4th edition of Drug Interactions in Infectious Diseases is being split into two separate volumes – “Mechanisms and Models of Drug Interactions” and “Antimicrobial Drug Interactions”. This volume, “Mechanisms and Models of Drug Interactions,” delivers a text that enhances clinical knowledge of the complex mechanisms, risks, and consequences of drug interactions associated with antimicrobials, infection, and inflammation. The book provides a comprehensive review of basic clinical pharmacology with a focus on metabolism and transporter-mediated drug interactions. The chapters address materials that cannot be retrieved easily in the medical literature, including materials focused on the complex interrelationship of acute infection, inflammation, and the risk of drug interactions in the Drug-Cytokine chapter. The Food-Drug and Herb-Drug interactions chapters remain definitive resources. A new chapter on in vitro modeling of drug interactions is included along with updates on design and data analysis of clinical drug interaction studies. Authoritative discussion of models for regulatory decision-making on drug-drug interactions provides the necessary framework to aid antimicrobial drug development. This concise review of the mechanisms and models of drug interactions provides important insights to health care practitioners as well as scientists in drug development.
A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals
Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates--especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors--into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry.
This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book.
Topics covered include:
Drug Approval Process and Regulatory Requirements (private standards)
Pharmacopeias and Compendial Approval Process (public standards)
Common methods in pharmaceutical analysis (typically compendial)
Common Calculations for assays and impurities and other specific tests
Analytical Method Validation, Verification, Transfer
Specifications including how to handle out of specification (OOS) and out of trend (OOT)
Impurities including organic, inorganic, residual solvents and elemental impurities
Good Documentation Practices for regulatory environment
Management of Analytical Laboratories
Analytical Instrument Qualifications including IQ, OQ, PQ and VQ
Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted.
Pharmaceutical Analysis for SmallMolecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.
Автор: Saharan Название: Computer Aided Pharmaceutics and Drug Delivery ISBN: 9811651795 ISBN-13(EAN): 9789811651793 Издательство: Springer Рейтинг: Цена: 30491.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book examines the role of computer-assisted techniques for discovering, designing, optimizing and manufacturing new, effective, and safe pharmaceutical formulations and drug delivery systems. The book discusses computational approaches, statistical modeling and molecular modeling for the development and safe delivery of drugs in humans. The application of concepts of QbD (Quality by Design), DoE (Design of Experiments), artificial intelligence and in silico pharmacokinetic assessment/simulation have been made a lot easier with the help of commercial software and expert systems. This title provides in-depth knowledge of such useful software with illustrations from the latest researches. The book also fills in the gap between pharmaceutics and molecular modeling at micro, meso and maro scale by covering topics such as advancements in computer-aided Drug Design (CADD), drug-polymer interactions in drug delivery systems, molecular modeling of nanoparticles and pharmaceutics/bioinformatics. This book provides abundant applications of computers in formulation designing and characterization are provided as examples, case studies and illustrations. Short reviews of software, databases and expert systems have also been added to culminate the interest of readers for novel applications in formulation development and drug delivery. Computer-aided pharmaceutics and drug delivery is an authoritative reference source for all the latest scholarly update on emerging developments in computed assisted techniques for drug designing and development. The book is ideally designed for pharmacists, medical practitioners, students and researchers.
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