Prof Of Drug Substances Excipients And Related Methodology
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| Author | : Harry G. Brittain |
| Publisher | : Academic Press |
| Total Pages | : 399 |
| Release | : 2011-07-15 |
| Genre | : Science |
| ISBN | : 0123877024 |
Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients. - Presents comprehensive reviews covering all aspects of drug development and formulation of drugs - Profiles creatine monohydrate and fexofenadine hydrochloride, as well as five others - Meets the information needs of the drug development community
| Author | : Abdulrahman Al-Majed |
| Publisher | : Academic Press |
| Total Pages | : 328 |
| Release | : 2021-01-16 |
| Genre | : Science |
| ISBN | : 0128241284 |
Profiles of Drug Substances, Excipients, and Related Methodology, Volume 46 contains comprehensive profiles of five drug compounds: Darunavir, Bisoprolol, Betaxolol, Rabeprazole and Irbesartan. In addition, the work contains a chapter reviewing Bioassay Methods and Their Applications in Herbal Drug Research. The comprehensive reviews in the book cover all aspects of drug development and the formulation of drugs, helping readers understand how the drug development community remains essential to all phases of pharmaceutical development. In addition, this work answers why such profiles are of immeasurable importance to workers in the field. The scope of the Profiles series encompasses review articles and database compilations that fall within one or more of the following five broad categories: Physical Profiles of Drug Substances and Excipients, Analytical Profiles of Drug Substances and Excipients, ADME Profiles of Drug Substances and Excipients, Methodology Related to the Characterization of Drug Substances and Excipients, and Methods of Chemical Synthesis. - Contains contributions from leading authorities - Presents an excellent overview on the physical, chemical and biomedical properties of some regularly prescribed drugs - Includes a cumulative index in each volume
| Author | : Otilia M. Y. Koo |
| Publisher | : John Wiley & Sons |
| Total Pages | : 369 |
| Release | : 2016-10-03 |
| Genre | : Medical |
| ISBN | : 1118992423 |
This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients
| Author | : Jack Zheng |
| Publisher | : John Wiley & Sons |
| Total Pages | : 506 |
| Release | : 2009-02-09 |
| Genre | : Medical |
| ISBN | : 0470056096 |
There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.
| Author | : Ajit S Narang |
| Publisher | : Springer |
| Total Pages | : 700 |
| Release | : 2015-10-07 |
| Genre | : Medical |
| ISBN | : 3319202065 |
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 | : |
| Publisher | : Academic Press |
| Total Pages | : 625 |
| Release | : 1994-09-05 |
| Genre | : Medical |
| ISBN | : 0080861180 |
Although the official compendia define a drug substance as to identity, purity, strength, and quality, they normally do not provide other physical or chemical data, nor do they list methods of synthesis or pathways of physical or biological degradation and metabolism. Such information is scattered throughout the scientific literature and the files of pharmaceutical laboratories. Edited by the Associate Director of Analytical Research and Development for the AmericanAssociation of Pharmaceutical Scientists, Analytical Profiles of Drug Substances and Excipients brings this information together into one source. The scope of the series has recently been expanded to include profiles of excipient materials.
| Author | : |
| Publisher | : Academic Press |
| Total Pages | : 783 |
| Release | : 1987-09-04 |
| Genre | : Science |
| ISBN | : 0080861113 |
Profiles of Drug Substances, Excipients and Related Methodology
| Author | : Geoffrey D Tovey |
| Publisher | : Royal Society of Chemistry |
| Total Pages | : 432 |
| Release | : 2018-06-25 |
| Genre | : Medical |
| ISBN | : 1849739412 |
Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to advances in processing technologies, result in growing challenges as well as possibilities for the field. Pharmaceutical Formulation provides an up to date source of information for all who wish to understand the principles and practice of formulation in the drug industry. The book provides an understanding of the links between formulation theory and the practicalities of processing in a commercial environment, giving researchers the knowledge to produce effective pharmaceutical products that can be approved and manufactured. The first chapters introduce readers to different dosage forms, including oral liquid products, topical products and solid dosage forms such as tablets and capsules. Subsequent chapters cover pharmaceutical coatings, controlled release drug delivery and dosage forms designed specifically for paediatric and geriatric patients. The final chapter provides an introduction to the vital role intellectual property plays in drug development. Covering modern processing methods and recent changes in the regulatory and quality demands of the industry, Pharmaceutical Formulation is an essential, up to date resource for students and researchers working in academia and in the pharmaceutical industry.
| Author | : Steen Honoré Hansen |
| Publisher | : John Wiley & Sons |
| Total Pages | : 511 |
| Release | : 2011-10-18 |
| Genre | : Science |
| ISBN | : 1119954339 |
This textbook is the first to present a systematic introduction to chemical analysis of pharmaceutical raw materials, finished pharmaceutical products, and of drugs in biological fluids, which are carried out in pharmaceutical laboratories worldwide. In addition, this textbook teaches the fundamentals of all the major analytical techniques used in the pharmaceutical laboratory, and teaches the international pharmacopoeias and guidelines of importance for the field. It is primarily intended for the pharmacy student, to teach the requirements in “analytical chemistry” for the 5 years pharmacy curriculum, but the textbook is also intended for analytical chemists moving into the field of pharmaceutical analysis. Addresses the basic concepts, then establishes the foundations for the common analytical methods that are currently used in the quantitative and qualitative chemical analysis of pharmaceutical drugs Provides an understanding of common analytical techniques used in all areas of pharmaceutical development Suitable for a foundation course in chemical and pharmaceutical sciences Aimed at undergraduate students of degrees in Pharmaceutical Science/Chemistry Analytical Science/Chemistry, Forensic analysis Includes many illustrative examples
| Author | : Walkiria S. Schlindwein |
| Publisher | : John Wiley & Sons |
| Total Pages | : 319 |
| Release | : 2018-01-05 |
| Genre | : Science |
| ISBN | : 1118895215 |
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
