Unit Operations In Pharmaceutical Engineering (Pb 2019), Sultana
Автор: Shah B. Название: Textbook Of Pharmacognosy And Phytochemistry 2Ed ISBN: 9386217732 ISBN-13(EAN): 9789386217738 Издательство: CBS India Рейтинг: Цена: 36580.00 T Наличие на складе: Есть
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: Amit Singh Название: Stimuli-Responsive Drug Delivery Systems ISBN: 1788011139 ISBN-13(EAN): 9781788011136 Издательство: Royal Society of Chemistry Рейтинг: Цена: 223870.00 T Наличие на складе: Нет в наличии. Описание: This book provides a comprehensive account on the design, materials chemistry, and application aspects behind these novel stimuli-responsive materials.
Автор: Hickey Название: Pharmaceutical Powder and Particles ISBN: 3319912194 ISBN-13(EAN): 9783319912196 Издательство: Springer Рейтинг: Цена: 121110.00 T Наличие на складе: Нет в наличии. Описание: This first monograph in the new AAPS book series concisely reviews important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance.
Автор: Alagarsamy V. Название: Textbook of Medicinal Chemistry, 3e Vol. 1 (PB) ISBN: 9385915495 ISBN-13(EAN): 9789385915499 Издательство: CBS India Рейтинг: Цена: 38320.00 T Наличие на складе: Нет в наличии. Описание: This popular textbook for pharmacy students provides all the information they need to know about medicinal chemistry. The third edition features new layout and design in an attractive two-colour presentation. It contains clear classifications, synthetic schemes, modes of action, metabolism, assay, pharmacological uses with the dose and structure activity relationship (SAR) of the drugs for the various body systems. Contains a complete section on drug design,describing the new drug development. Includes an introduction to the physiological and pathophysiological conditions of diseases and their treatment. Provides well-illustrated synthetic schemes and alternative synthetic routes for the majority of drugs. Additional physico-chemical parameters have been explained.
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: Sharma H.K. Название: Textbook Of Pharmaceutical Calculation And Extemporaneous Preparations (Pb 2019) ISBN: 9388178912 ISBN-13(EAN): 9789388178914 Издательство: CBS India Рейтинг: Цена: 17420.00 T Наличие на складе: Нет в наличии. Описание: This is an ideal textbook for the students of pharmacy, biotechnology and basic sciences. It is also a valuable reference for pharmacists working in industry and institutions.
Автор: Austin, Martin Название: Business development for the biotechnology and pharmaceutical industry ISBN: 0566087812 ISBN-13(EAN): 9780566087813 Издательство: Taylor&Francis Рейтинг: Цена: 148010.00 T Наличие на складе: Невозможна поставка. Описание: Business Development in the Biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. This book spans the process.
Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the
USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.
Автор: Watson, David G. (Senior Lecturer in Pharmaceutical Sciences, Strathclyde Institute of Pharmaceutical and Biomedical Sciences, University of Strathcly Название: Pharmaceutical and Medicinal Chemistry. Elsevier,2011 ISBN: 9780443072321\Давид Уотсон:Фармацевтическая и лекарственная химия, Элзивир,2011 ISBN: 0443072329 ISBN-13(EAN): 9780443072321 Издательство: Elsevier Science Рейтинг: Цена: 49390.00 T Наличие на складе: Нет в наличии. 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: Lal, H. Название: Essentials of Pharmaceutical Biochemistry: CBS Publishers & Distributrors, 2019.- ISBN: 9789386478580 /Основы фармацевтической биохимии, включая практические упражнения ISBN: 9386478587 ISBN-13(EAN): 9789386478580 Издательство: CBS India Рейтинг: Цена: 31350.00 T Наличие на складе: Нет в наличии. Описание: This book includes all of the theory as well as the practical side of pharmaceutical biochemistry, presented in a simple, yet comprehensive, way. It includes chapters on topics such as biomolecules, biogeneratics, energy rich compounds, biological oxidation, the catalytic role of enzymes, the importance of enzyme inhibitors in the design of new drugs, and therapeutic and diagnostic applications of enzymes.
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