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Author : Jerome Irwin Bodin
Publisher :
ISBN 13 :
Total Pages : 878 pages
Book Rating : 4.3/5 (91 download)
Download or read book Pharmaceutical Analysis written by Jerome Irwin Bodin and published by . This book was released on 1961 with total page 878 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Anette Müllertz
Publisher : Springer
ISBN 13 : 1493940295
Total Pages : 829 pages
Book Rating : 4.4/5 (939 download)
Download or read book Analytical Techniques in the Pharmaceutical Sciences written by Anette Müllertz and published by Springer. This book was released on 2016-08-30 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.
Author : Yuri V. Kazakevich
Publisher : John Wiley & Sons
ISBN 13 : 0470087943
Total Pages : 1136 pages
Book Rating : 4.4/5 (7 download)
Download or read book HPLC for Pharmaceutical Scientists written by Yuri V. Kazakevich and published by John Wiley & Sons. This book was released on 2007-02-16 with total page 1136 pages. Available in PDF, EPUB and Kindle. Book excerpt: HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.
Author : Lawrence A. Trissel
Publisher : American Pharmacists Association (APhA)
ISBN 13 :
Total Pages : 456 pages
Book Rating : 4.3/5 (91 download)
Download or read book Trissel's Stability of Compounded Formulations written by Lawrence A. Trissel and published by American Pharmacists Association (APhA). This book was released on 2000 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Helps readers determine whether formulated compounds will be stable for the anticipated duration of use; properly store and repackage compounded formulations; formulate in accordance with documented standards; and, counsel patients on the use and storate of comounded medications." -- Back cover.
Author : Ajit S Narang
Publisher : Springer
ISBN 13 : 3319202065
Total Pages : 700 pages
Book Rating : 4.3/5 (192 download)
Download or read book Excipient Applications in Formulation Design and Drug Delivery written by Ajit S Narang and published by Springer. This book was released on 2015-10-07 with total page 700 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.
Author : Justyna Płotka-Wasylka
Publisher : Springer
ISBN 13 : 981139105X
Total Pages : 460 pages
Book Rating : 4.8/5 (113 download)
Download or read book Green Analytical Chemistry written by Justyna Płotka-Wasylka and published by Springer. This book was released on 2019-08-02 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book explains the principles and fundamentals of Green Analytical Chemistry (GAC) and highlights the current developments and future potential of the analytical green chemistry-oriented applications of various solutions. The book consists of sixteen chapters, including the history and milestones of GAC; issues related to teaching of green analytical chemistry and greening the university laboratories; evaluation of impact of analytical activities on the environmental and human health, direct techniques of detection, identification and determination of trace constituents; new achievements in the field of extraction of trace analytes from samples characterized by complex composition of the matrix; “green” nature of the derivatization process in analytical chemistry; passive techniques of sampling of analytes; green sorption materials used in analytical procedures; new types of solvents in the field of analytical chemistry. In addition green chromatography and related techniques, fast tests for assessment of the wide spectrum of pollutants in the different types of the medium, remote monitoring of environmental pollutants, qualitative and comparative evaluation, quantitative assessment, and future trends and perspectives are discussed. This book appeals to a wide readership of the academic and industrial researchers. In addition, it can be used in the classroom for undergraduate and graduate Ph.D. students focusing on elaboration of new analytical procedures for organic and inorganic compounds determination in different kinds of samples characterized by complex matrices composition.Jacek Namieśnik was a Professor at the Department of Analytical Chemistry, Gdańsk University of Technology, Poland. Justyna Płotka-Wasylka is a teacher and researcher at the same department.
Author : Alok K. Kulshreshtha
Publisher : Springer Science & Business Media
ISBN 13 : 1441910875
Total Pages : 337 pages
Book Rating : 4.4/5 (419 download)
Download or read book Pharmaceutical Suspensions written by Alok K. Kulshreshtha and published by Springer Science & Business Media. This book was released on 2009-11-05 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Michael Gruss
Publisher : John Wiley & Sons
ISBN 13 : 352734635X
Total Pages : 578 pages
Book Rating : 4.5/5 (273 download)
Download or read book Solid State Development and Processing of Pharmaceutical Molecules written by Michael Gruss and published by John Wiley & Sons. This book was released on 2021-11-15 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: Solid State Development and Processing of Pharmaceutical Molecules A guide to the lastest industry principles for optimizing the production of solid state active pharmaceutical ingredients Solid State Development and Processing of Pharmaceutical Molecules is an authoritative guide that covers the entire pharmaceutical value chain. The authors—noted experts on the topic—examine the importance of the solid state form of chemical and biological drugs and review the development, production, quality control, formulation, and stability of medicines. The book explores the most recent trends in the digitization and automation of the pharmaceutical production processes that reflect the need for consistent high quality. It also includes information on relevant regulatory and intellectual property considerations. This resource is aimed at professionals in the pharmaceutical industry and offers an in-depth examination of the commercially relevant issues facing developers, producers and distributors of drug substances. This important book: Provides a guide for the effective development of solid drug forms Compares different characterization methods for solid state APIs Offers a resource for understanding efficient production methods for solid state forms of chemical and biological drugs Includes information on automation, process control, and machine learning as an integral part of the development and production workflows Covers in detail the regulatory and quality control aspects of drug development Written for medicinal chemists, pharmaceutical industry professionals, pharma engineers, solid state chemists, chemical engineers, Solid State Development and Processing of Pharmaceutical Molecules reviews information on the solid state of active pharmaceutical ingredients for their efficient development and production.
Author : Mukesh Maithani
Publisher : Springer
ISBN 13 : 9811387230
Total Pages : 117 pages
Book Rating : 4.8/5 (113 download)
Download or read book Development of Novel Stability Indicating Methods Using Liquid Chromatography written by Mukesh Maithani and published by Springer. This book was released on 2019-08-07 with total page 117 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reversed-phase high-performance liquid chromatography (RP-HPLC) has become the most widely used method for pharmaceutical analysis, as it ensures accuracy, specificity and reproducibility for the quantification of drugs, while avoiding interference from any of the excipients that are normally present in pharmaceutical dosage forms. This book presents a simple methodology for developing stability-indicating methods and offers a ‘how-to guide’ to creating novel stability-indicating methods using liquid chromatography. It provides the detailed information needed to devise a stability-indicating method for drug substances and drug products that comply with international regulatory guidelines. As such, it is a must-read for anyone engaged in analytical and bioanalytical chemistry: professionals at reference, test, and control laboratories; students and academics at research laboratories, and scientists working for chemical, pharmaceutical, and biotechnology companies.
Author : David J. Hauss
Publisher : CRC Press
ISBN 13 : 1420017268
Total Pages : 370 pages
Book Rating : 4.4/5 (2 download)
Download or read book Oral Lipid-Based Formulations written by David J. Hauss and published by CRC Press. This book was released on 2007-06-08 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral lipid-based formulations are attracting considerable attention due to their capacity to facilitate gastrointestinal absorption and reduce or eliminate the effect of food on the absorption of poorly water-soluble, lipophilic drugs. Despite the obvious and demonstrated utility of these formulations for addressing a persistent and growing problem
Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 1420048457
Total Pages : 258 pages
Book Rating : 4.4/5 (2 download)
Download or read book Handbook of Pharmaceutical Manufacturing Formulations written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2004-04-27 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emul
Author : P. Heinrich Stahl
Publisher : John Wiley & Sons
ISBN 13 : 9783906390581
Total Pages : 392 pages
Book Rating : 4.3/5 (95 download)
Download or read book Handbook of Pharmaceutical Salts Properties, Selection, and Use written by P. Heinrich Stahl and published by John Wiley & Sons. This book was released on 2008-08-04 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive up-to-date guide and information source is an instructive companion for all scientists involved in research and development of drugs and, in particular, of pharmaceutical dosage forms. The editors have taken care to address every conceivable aspect of the preparation of pharmaceutical salts and present the necessary theoretical foundations as well as a wealth of detailed practical experience in the choice of pharmaceutically active salts. Altogether, the contributions reflect the multidisciplinary nature of the science involved in selection of suitable salt forms for new drug products.
Author : B.A. Bidlingmeyer
Publisher : Elsevier
ISBN 13 : 0080858414
Total Pages : 357 pages
Book Rating : 4.0/5 (88 download)
Download or read book Preparative Liquid Chromatography written by B.A. Bidlingmeyer and published by Elsevier. This book was released on 1987-07-01 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume provides a straightforward approach to isolation and purification problems with a thorough presentation of preparative LC strategy including the interrelationship between the input and output of the instrumentation, while keeping to an application focus.The book stresses the practical aspects of preparative scale separations from TLC isolations through various laboratory scale column separations to very large scale production. It also gives a thorough description of the performance parameters (e.g. throughput, separation quality, etc.) as a function of operational parameters (e.g. particle size, column size, solvent usage, etc.). Experts in the field have contributed a well balanced presentation of separation development strategies from preparative TLC to commercial preparative process with practical examples in a wide variety of application areas such as drugs, proteins, nucleotides, industrial extracts, organic chemicals, enantiomers, polymers, etc.
Author : Yuriy A. Abramov
Publisher : John Wiley & Sons
ISBN 13 : 1119229197
Total Pages : 440 pages
Book Rating : 4.1/5 (192 download)
Download or read book Computational Pharmaceutical Solid State Chemistry written by Yuriy A. Abramov and published by John Wiley & Sons. This book was released on 2016-05-20 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the first to combine computational material science and modeling of molecular solid states for pharmaceutical industry applications. • Provides descriptive and applied state-of-the-art computational approaches and workflows to guide pharmaceutical solid state chemistry experiments and to support/troubleshoot API solid state selection • Includes real industrial case examples related to application of modeling methods in problem solving • Useful as a supplementary reference/text for undergraduate, graduate and postgraduate students in computational chemistry, pharmaceutical and biotech sciences, and materials science
Author : Wenkui Li
Publisher : John Wiley & Sons
ISBN 13 : 111867135X
Total Pages : 709 pages
Book Rating : 4.1/5 (186 download)
Download or read book Handbook of LC-MS Bioanalysis written by Wenkui Li and published by John Wiley & Sons. This book was released on 2013-09-03 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.
Author : Anurag S. Rathore
Publisher : John Wiley & Sons
ISBN 13 : 1118210913
Total Pages : 279 pages
Book Rating : 4.1/5 (182 download)
Download or read book Quality by Design for Biopharmaceuticals written by Anurag S. Rathore and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
Author : Ruben Vardanyan
Publisher : Academic Press
ISBN 13 : 0124115241
Total Pages : 870 pages
Book Rating : 4.1/5 (241 download)
Download or read book Synthesis of Best-Seller Drugs written by Ruben Vardanyan and published by Academic Press. This book was released on 2016-01-07 with total page 870 pages. Available in PDF, EPUB and Kindle. Book excerpt: Synthesis of Best-Seller Drugs is a key reference guide for all those involved with the design, development, and use of the best-selling drugs. Designed for ease of use, this book provides detailed information on the most popular drugs, using a practical layout arranged according to drug type. Each chapter reviews the main drugs in each of nearly 40 key therapeutic areas, also examining their classification, novel structural features, models of action, and synthesis. Of high interest to all those who work in the captivating areas of biologically active compounds and medicinal drug synthesis, in particular medicinal chemists, biochemists, and pharmacologists, the book aims to support current research efforts, while also encouraging future developments in this important field. - Describes methods of synthesis, bioactivity and related drugs in key therapeutic areas - Reviews the main drugs in each of nearly 40 key therapeutic areas, also examining their classification, novel structural features, models of action, and more - Presents a practical layout designed for use as a quick reference tool by those working in drug design, development and implementation
