Download or read book Profiles of Drug Substances Excipients and Related Methodology written by Harry G. Brittain and published by Academic Press. This book was released on 2011-07-15 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Prof of Drug Substances Excipients and Related Methodology written by Abdulrahman Al-Majed and published by Academic Press. This book was released on 2021-01-16 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Profiles of Drug Substances Excipients and Related Methodology written by and published by Academic Press. This book was released on 2017-04-19 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: Profiles of Drug Substances, Excipients, and Related Methodology, Volume 42 presents comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients, thus meeting the needs of the pharmaceutical community and allowing for the development of a timely vehicle for publishing review materials on the topic. This latest release covers a variety of substances, including Cinacalcet Hydrochloride, Clenbuterol Hydrochloride, Gliclazide, Lomefloxacin, Olmesartan, Propranolol, and Tolterodine Tartrate. 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. - Contains contributions from leading authorities - Informs and updates on all the latest developments in the field

Download or read book Pharmaceutical Excipients written by Otilia M. Y. Koo and published by John Wiley & Sons. This book was released on 2016-10-03 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

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.

Download or read book Profiles of Drug Substances Excipients and Related Methodology written by Abdulrahman Al-Majed and published by Academic Press. This book was released on 2022-04-06 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Profiles of Drug Substances, Excipients, and Related Methodology, Volume 47 covers all aspects of drug development and formulation of drugs, meeting the information needs of the drug development community that are essential to all phases of pharmaceutical development. This updated release includes comprehensive profiles of five drug compounds: Vinpocetine; Loratadine; Ticagrelor; Lodenafil; Danazol. The volume also contains a chapter reviewing "Application of Chemometrics using direct Spectroscopic methods as a QC tool in Pharmaceutical Industry and their Validation. - Contains contributions from leading authorities - Presents an excellent overview of the physical, chemical and biomedical properties of regularly prescribed drugs - Contains a cumulative index for easy access to information

Download or read book Formulation and Analytical Development for Low Dose Oral Drug Products written by Jack Zheng and published by John Wiley & Sons. This book was released on 2009-02-09 with total page 506 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Analytical Profiles of Drug Substances and Excipients written by and published by Academic Press. This book was released on 1994-09-05 with total page 625 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Profiles of Drug Substances Excipients and Related Methodology written by Harry G. Brittain and published by Academic Press. This book was released on 2010-02-27 with total page 407 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Introduction to Pharmaceutical Chemical Analysis written by Steen Honoré Hansen and published by John Wiley & Sons. This book was released on 2011-10-18 with total page 511 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Pharmaceutical Formulation written by Geoffrey D Tovey and published by Royal Society of Chemistry. This book was released on 2018-06-25 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-05 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Analytical Profiles of Drug Substances written by Klaus Florey and published by . This book was released on 1990 with total page 666 pages. Available in PDF, EPUB and Kindle. Book excerpt: Intended for medicinal, pharmaceutical and analytical chemists, this book brings together information detailing physical and chemical data defining a drug, and various methods of synthesis of biological/physical degradation and metabolism.

Download or read book Handbook of Isolation and Characterization of Impurities in Pharmaceuticals written by Satinder Ahuja and published by Elsevier. This book was released on 2003-06-26 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.- Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.

Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Download or read book Excipient Development for Pharmaceutical Biotechnology and Drug Delivery Systems written by Ashok Katdare and published by CRC Press. This book was released on 2006-07-28 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.

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.